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FDA 510(k)

MODIFIED RETINAL CAMERA MODEL CR4-45NM

K-Number: K874017 · 1987-11-02

ApplicantCanon USA, Inc.
Decision Date1987-11-02
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MODIFIED RETINAL CAMERA MODEL CR4-45NM 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 1987-11-02 under 510(k) number K874017. 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 MODIFIED RETINAL CAMERA MODEL CR4-45NM?

MODIFIED RETINAL CAMERA MODEL CR4-45NM is a medical device that received FDA 510(k) clearance on 1987-11-02. The listed applicant is Canon USA, Inc.. The 510(k) number is K874017.

When did MODIFIED RETINAL CAMERA MODEL CR4-45NM receive FDA 510(k) clearance?

MODIFIED RETINAL CAMERA MODEL CR4-45NM received FDA 510(k) clearance on 1987-11-02, under 510(k) number K874017.

Who is the listed applicant for MODIFIED RETINAL CAMERA MODEL CR4-45NM?

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 MODIFIED RETINAL CAMERA MODEL CR4-45NM?

The FDA product code for MODIFIED RETINAL CAMERA MODEL CR4-45NM 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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