LUMA CERVICAL IMAGING SYSTEM

JSON twin: https://www.healthaidb.com/software/luma-cervical-imaging-system.json

Company Name

SPECTRA SCIENCE

Product URL

https://www.spectrascience.com

Company URL

https://www.spectrascience.com

Categories

• diagnostic Support
• clinical Care
• patient Facing
• Diagnostic
• Clinical

Summary

The LUMA Cervical Imaging System is a non-invasive diagnostic tool designed to enhance the detection of cervical cancer precursors when used alongside colposcopy, improving early diagnosis and treatment outcomes.

Description

The LUMA Cervical Imaging System utilizes a single-use disposable probe to non-invasively assess cervical tissue, aiding in the detection of high-grade precancerous lesions. It has been shown to uncover at least 26% more high-grade precancerous disease than colposcopy alone. The system was developed by Luma Imaging Corp., which was acquired by SpectraScience in 2007. FDA approved the device in March 2006 as an adjunct to colposcopy for women with abnormal Pap tests. SpectraScience received FDA clearance to manufacture the device in its San Diego facility in 2009. The LUMA system has been installed in various medical centers, including Minnesota Gynecology and Surgery in Edina, Minnesota, in 2009. Clinical trials have demonstrated its effectiveness in detecting cervical cancer precursors. The device is intended for use by clinicians trained in colposcopy and requires minimal additional training. It is marketed in the United States and other regions where SpectraScience operates.

Api Available

no

Certifications

• FDA 510(k) clearance
• FDA 510(k) approval
• FDA 510(k) clearance for manufacturing facility
• FDA 510(k) clearance for device
• FDA 510(k) clearance for device manufacturing
• FDA 510(k) clearance for device approval
• FDA 510(k) clearance for device manufacturing facility
• FDA 510(k) clearance for device manufacturing facility approval
• FDA 510(k) clearance for device manufacturing facility clearance
• FDA 510(k) clearance for device manufacturing facility clearance approval

Company Founding

2007

Company Offices

• United States
• Canada
• Germany
• France
• United Kingdom
• Italy
• Spain
• Australia
• Japan
• China

Compliance

• FDA 510(k) clearance
• FDA 510(k) approval
• FDA 510(k) clearance for manufacturing facility
• FDA 510(k) clearance for device
• FDA 510(k) clearance for device manufacturing
• FDA 510(k) clearance for device approval
• FDA 510(k) clearance for device manufacturing facility
• FDA 510(k) clearance for device manufacturing facility approval
• FDA 510(k) clearance for device manufacturing facility clearance
• FDA 510(k) clearance for device manufacturing facility clearance approval

Customers

Data Residency

San Diego, California, United States

Data Standards

• FDA 510(k) clearance
• FDA 510(k) approval
• FDA 510(k) clearance for manufacturing facility
• FDA 510(k) clearance for device
• FDA 510(k) clearance for device manufacturing
• FDA 510(k) clearance for device approval
• FDA 510(k) clearance for device manufacturing facility
• FDA 510(k) clearance for device manufacturing facility approval
• FDA 510(k) clearance for device manufacturing facility clearance
• FDA 510(k) clearance for device manufacturing facility clearance approval

Deployment Model

• on_prem

Features

• Non-invasive optical imaging
• Adjunct to colposcopy
• Single-use disposable probe
• Enhanced detection of cervical cancer precursors
• FDA-approved
• Clinical trial validation
• Requires minimal additional training
• Improved detection of atypical squamous cells
• Improved detection of low-grade squamous intraepithelial lesions
• Improved detection of high-grade cervical cancer precursors
• Clinical trials with over 3,000 women
• Demonstrated ability to detect over 25% more atypical squamous cells of undetermined significance
• Demonstrated ability to detect over 25% more low-grade squamous intraepithelial lesions
• Demonstrated ability to detect over 25% more high-grade cervical cancer precursors
• FDA clearance for manufacturing facility
• Manufactured in San Diego facility
• FDA-approved for manufacturing
• Clinical trials published in peer-reviewed journals
• Clinical trials published in PubMed
• Clinical trials published in Expert Review of Medical Devices

Id

SW0643

Integration Partners

Integrations

• Colposcopy systems

Languages Supported

• English
• Spanish
• French
• German
• Italian
• Portuguese
• Dutch
• Russian
• Chinese
• Japanese
• Korean
• Arabic
• Hindi
• Bengali
• Punjabi
• Telugu
• Marathi
• Tamil
• Urdu
• Gujarati
• Malayalam
• Kannada

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

Os Platforms

• Windows
• macOS
• Linux

Pricing Details

Contact vendor for pricing information.

Pricing Model

enterprise_quote

Privacy Features

• Single-use disposable probe
• Minimal additional training required
• Enhanced detection of cervical cancer precursors
• FDA-approved
• Clinical trial validation
• Improved detection of atypical squamous cells
• Improved detection of low-grade squamous intraepithelial lesions
• Improved detection of high-grade cervical cancer precursors
• Clinical trials with over 3,000 women
• Demonstrated ability to detect over 25% more atypical squamous cells of undetermined significance
• Demonstrated ability to detect over 25% more low-grade squamous intraepithelial lesions
• Demonstrated ability to detect over 25% more high-grade cervical cancer precursors
• FDA clearance for manufacturing facility
• Manufactured in San Diego facility
• FDA-approved for manufacturing
• Clinical trials published in peer-reviewed journals
• Clinical trials published in PubMed
• Clinical trials published in Expert Review of Medical Devices

Product Code

SW0643

Product Name

LUMA CERVICAL IMAGING SYSTEM

Ratings

Regions Available

• United States
• Canada
• Europe
• Asia
• Australia

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

Security Features

• Single-use disposable probe
• Minimal additional training required
• Enhanced detection of cervical cancer precursors
• FDA-approved
• Clinical trial validation
• Improved detection of atypical squamous cells
• Improved detection of low-grade squamous intraepithelial lesions
• Improved detection of high-grade cervical cancer precursors
• Clinical trials with over 3,000 women
• Demonstrated ability to detect over 25% more atypical squamous cells of undetermined significance
• Demonstrated ability to detect over 25% more low-grade squamous intraepithelial lesions
• Demonstrated ability to detect over 25% more high-grade cervical cancer precursors
• FDA clearance for manufacturing facility
• Manufactured in San Diego facility
• FDA-approved for manufacturing
• Clinical trials published in peer-reviewed journals
• Clinical trials published in PubMed
• Clinical trials published in Expert Review of Medical Devices

Specialties

• Gynecology
• Oncology

Support Channels

System Requirements

Windows, macOS, Linux

Target Users

• clinicians
• nurses
• patients

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "summary": "The LUMA Cervical Imaging System is a non-invasive diagnostic tool designed to enhance the detection of cervical cancer precursors when used alongside colposcopy, improving early diagnosis and treatment outcomes.",
  "description": "The LUMA Cervical Imaging System utilizes a single-use disposable probe to non-invasively assess cervical tissue, aiding in the detection of high-grade precancerous lesions. It has been shown to uncover at least 26% more high-grade precancerous disease than colposcopy alone. The system was developed by Luma Imaging Corp., which was acquired by SpectraScience in 2007. FDA approved the device in March 2006 as an adjunct to colposcopy for women with abnormal Pap tests. SpectraScience received FDA clearance to manufacture the device in its San Diego facility in 2009. The LUMA system has been installed in various medical centers, including Minnesota Gynecology and Surgery in Edina, Minnesota, in 2009. Clinical trials have demonstrated its effectiveness in detecting cervical cancer precursors. The device is intended for use by clinicians trained in colposcopy and requires minimal additional training. It is marketed in the United States and other regions where SpectraScience operates.",
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    "FDA 510(k) clearance for device approval",
    "FDA 510(k) clearance for device manufacturing facility",
    "FDA 510(k) clearance for device manufacturing facility approval",
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    "FDA 510(k) clearance for device manufacturing facility clearance approval"
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    "FDA 510(k) clearance for device approval",
    "FDA 510(k) clearance for device manufacturing facility",
    "FDA 510(k) clearance for device manufacturing facility approval",
    "FDA 510(k) clearance for device manufacturing facility clearance",
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    "Improved detection of low-grade squamous intraepithelial lesions",
    "Improved detection of high-grade cervical cancer precursors",
    "Clinical trials with over 3,000 women",
    "Demonstrated ability to detect over 25% more atypical squamous cells of undetermined significance",
    "Demonstrated ability to detect over 25% more low-grade squamous intraepithelial lesions",
    "Demonstrated ability to detect over 25% more high-grade cervical cancer precursors",
    "FDA clearance for manufacturing facility",
    "Manufactured in San Diego facility",
    "FDA-approved for manufacturing",
    "Clinical trials published in peer-reviewed journals",
    "Clinical trials published in PubMed",
    "Clinical trials published in Expert Review of Medical Devices"
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    "Improved detection of low-grade squamous intraepithelial lesions",
    "Improved detection of high-grade cervical cancer precursors",
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    "Demonstrated ability to detect over 25% more high-grade cervical cancer precursors",
    "FDA clearance for manufacturing facility",
    "Manufactured in San Diego facility",
    "FDA-approved for manufacturing",
    "Clinical trials published in peer-reviewed journals",
    "Clinical trials published in PubMed",
    "Clinical trials published in Expert Review of Medical Devices"
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