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FDA 510(k)

IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM

K-Number: K971685 · 1997-06-24

ApplicantTomey Corporation USA
Decision Date1997-06-24
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tomey Corporation USA. It received FDA 510(k) clearance on 1997-06-24 under 510(k) number K971685. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM?

IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM is a medical device that received FDA 510(k) clearance on 1997-06-24. The listed applicant is Tomey Corporation USA. The 510(k) number is K971685.

When did IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM receive FDA 510(k) clearance?

IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM received FDA 510(k) clearance on 1997-06-24, under 510(k) number K971685.

Who is the listed applicant for IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM?

The FDA 510(k) record lists Tomey Corporation USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM?

The FDA product code for IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM is HKI.

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Other records listing Tomey Corporation USA as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K971953CONFOSCANK961805TOMEY DTL ELECTRODEK932571TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4K945959VIDEO VISION ANALYZER (VIVA), VRB 100K944910TOMEY EM-1000 SPECULAR MICROSCOPEK924760TOMEY PROTON TONOMETER

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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