Gynescope Image acquistion system IL-100-100-200

GUDID 67290018240016

The Gynescope™ is an imaging colposcope. The Gynescope™ provides high resolution imaging optics comprised of multi-spectral (White and Green) illumination and multi-angle illumination dark field (side illumination) and bright field (centered illumination) techniques, reinforced with dual imaging sensor design (a color imaging sensor and a high sensitivity monochrome sensor). The monochrome sensor and the color sensor have the same optical path. The optical design uses a beam splitter adjacent to both of the sensors (at the end of the optical path). The Gynescope™ is a compact colposcope platform for physicians to perform examinations of the cervix, combined with a working space for interventional procedures. The Gynescope™ includes an Image Acquisition System

ILLUMIGYN LTD

Video colposcope camera/monitor

• Primary Device ID: 67290018240016
• NIH Device Record Key: 39c73110-d6e6-4201-bb5f-6463d57cf6eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gynescope Image acquistion system
• Version Model Number: 01
• Catalog Number: IL-100-100-200
• Company DUNS: 600627621
• Company Name: ILLUMIGYN LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +97225476319
• Email: Support@illumigyn.com
• Phone: +97225476319
• Email: Support@illumigyn.com
• Phone: +97225476319
• Email: Support@illumigyn.com
• Phone: +97225476319
• Email: Support@illumigyn.com
• Phone: +97225476319
• Email: Support@illumigyn.com
• Phone: +97225476319
• Email: Support@illumigyn.com
• Phone: +97225476319
• Email: Support@illumigyn.com
• Phone: +97225476319
• Email: Support@illumigyn.com
• Phone: +97225476319
• Email: Support@illumigyn.com
• Phone: +97225476319
• Email: Support@illumigyn.com
• Phone: +97225476319
• Email: Support@illumigyn.com
• Phone: +97225476319
• Email: Support@illumigyn.com
• Phone: +97225476319
• Email: Support@illumigyn.com
• Phone: +97225476319
• Email: Support@illumigyn.com
• Phone: +97225476319
• Email: Support@illumigyn.com
• Phone: +97225476319
• Email: Support@illumigyn.com
• Phone: +97225476319
• Email: Support@illumigyn.com
• Phone: +97225476319
• Email: Support@illumigyn.com
• Phone: +97225476319
• Email: Support@illumigyn.com
• Phone: +97225476319
• Email: Support@illumigyn.com
• Phone: +97225476319
• Email: Support@illumigyn.com
• Phone: +97225476319
• Email: Support@illumigyn.com
• Phone: +97225476319
• Email: Support@illumigyn.com
• Phone: +97225476319
• Email: Support@illumigyn.com
• Phone: +97225476319
• Email: Support@illumigyn.com
• Phone: +97225476319
• Email: Support@illumigyn.com
• Phone: +97225476319
• Email: Support@illumigyn.com
• Phone: +97225476319
• Email: Support@illumigyn.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	67290018240016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190187

FDA Product Code

• HEX: Colposcope (And Colpomicroscope)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-04
• Device Publish Date: 2020-11-26

Devices Manufactured by ILLUMIGYN LTD

• 57290018240026 - Gynescope, console system: 2020-12-04 Gynescope™ system console for image capturing and digital image archiving
• 67290018240016 - Gynescope Image acquistion system: 2020-12-04The Gynescope™ is an imaging colposcope. The Gynescope™ provides high resolution imaging optics comprised of multi-spectral (White and Green) illumination and multi-angle illumination dark field (side illumination) and bright field (centered illumination) techniques, reinforced with dual imaging sensor design (a color imaging sensor and a high sensitivity monochrome sensor). The monochrome sensor and the color sensor have the same optical path. The optical design uses a beam splitter adjacent to both of the sensors (at the end of the optical path). The Gynescope™ is a compact colposcope platform for physicians to perform examinations of the cervix, combined with a working space for interventional procedures. The Gynescope™ includes an Image Acquisition System
• 67290018240016 - Gynescope Image acquistion system: 2020-12-04 The Gynescope™ is an imaging colposcope. The Gynescope™ provides high resolution imaging optics comprised of multi-spectral
• 77290018240013 - Gynescope system, cart: 2020-12-04 Gynescope system, cart
• 17290018240011 - GYNESCOPE , SYSTEM (CONSOLE, IMAGE ACQUISTION SYSTEM-1 pcs: 2020-11-30 GYNESCOPE , SYSTEM (CONSOLE, IMAGE ACQUISTION SYSTEM-1 pcs
• 27290018240018 - Gynescope single use vaginal speculume size small 60 units: 2020-10-05 Indications for Use Gynescope single Use Vaginal Speculum The disposable vaginal speculum is used to dilate the vagina and expo
• 37290018240015 - Gynescope single use vaginal speculum size medium 60 units: 2020-10-05 Indications for Use Gynescope Single Use Vaginal Speculum The disposable vaginal speculum is used to dilate the vagina and expo
• 47290018240012 - Gynescope single use vaginal speculum size large 60 units: 2020-10-05 Indications for Use Gynescope Single Use Vaginal Speculum The disposable vaginal speculum is used to dilate the vagina and expo
• 57290018240019 - Gynescope single use vaginal speculum size Sm + Md + Lrg 20 pcs each: 2020-10-05 20 units with small size 20 units with medium size 20 units with lager size. Indications for Use Gynescope Single Use Vaginal Sp