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FDA 510(k)

CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI

K-Number: K031629 · 2003-06-06

ApplicantCanon USA, Inc.
Decision Date2003-06-06
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI 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 2003-06-06 under 510(k) number K031629. 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 CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI?

CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI is a medical device that received FDA 510(k) clearance on 2003-06-06. The listed applicant is Canon USA, Inc.. The 510(k) number is K031629.

When did CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI receive FDA 510(k) clearance?

CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI received FDA 510(k) clearance on 2003-06-06, under 510(k) number K031629.

Who is the listed applicant for CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI?

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 CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI?

The FDA product code for CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI 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-40CK023750CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40GK023586DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERASK003689CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31

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Related Devices (Code: HKI)

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Official Source

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

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