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FDA 510(k)

NON-MYDRIATIC RETINAL CAMERA

K-Number: K941234 · 1995-06-07

ApplicantCanon USA, Inc.
Decision Date1995-06-07
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NON-MYDRIATIC RETINAL CAMERA is the device name listed in this FDA 510(k) record. The listed applicant is Canon USA, Inc.. It received FDA 510(k) clearance on 1995-06-07 under 510(k) number K941234. 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 NON-MYDRIATIC RETINAL CAMERA?

NON-MYDRIATIC RETINAL CAMERA is a medical device that received FDA 510(k) clearance on 1995-06-07. The listed applicant is Canon USA, Inc.. The 510(k) number is K941234.

When did NON-MYDRIATIC RETINAL CAMERA receive FDA 510(k) clearance?

NON-MYDRIATIC RETINAL CAMERA received FDA 510(k) clearance on 1995-06-07, under 510(k) number K941234.

Who is the listed applicant for NON-MYDRIATIC RETINAL CAMERA?

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

What is the FDA product code for NON-MYDRIATIC RETINAL CAMERA?

The FDA product code for NON-MYDRIATIC RETINAL CAMERA is HKI.

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Other records listing Canon USA, Inc. 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.

K090623DIGITAL RADIOGRAPHY CXDI-40G COMPACTK033624PACS SOFTWARE SOLUTION 2003K031633CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40CK031629CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGIK023750CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40GK023586DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS

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Related Devices (Code: HKI)

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.

K253176TearViewBeyond 700 Pty, Ltd.K251353Eyer 2Phelcom TechnologiesK252120Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private LimitedK250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.LtdK250683Resolve Fundus CameraOptain Health, Inc.

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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