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FDA 510(k)

CANON X-RAY 35MM CINE CAMERA CSI-35

K-Number: K853983 · 1985-10-16

ApplicantCanon USA, Inc.
Decision Date1985-10-16
Product CodeIZJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CANON X-RAY 35MM CINE CAMERA CSI-35 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 1985-10-16 under 510(k) number K853983. The device is classified under product code IZJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CANON X-RAY 35MM CINE CAMERA CSI-35?

CANON X-RAY 35MM CINE CAMERA CSI-35 is a medical device that received FDA 510(k) clearance on 1985-10-16. The listed applicant is Canon USA, Inc.. The 510(k) number is K853983.

When did CANON X-RAY 35MM CINE CAMERA CSI-35 receive FDA 510(k) clearance?

CANON X-RAY 35MM CINE CAMERA CSI-35 received FDA 510(k) clearance on 1985-10-16, under 510(k) number K853983.

Who is the listed applicant for CANON X-RAY 35MM CINE CAMERA CSI-35?

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 X-RAY 35MM CINE CAMERA CSI-35?

The FDA product code for CANON X-RAY 35MM CINE CAMERA CSI-35 is IZJ.

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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: IZJ)

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.

K024085CCD CAMERA, MODEL PKP-06000-000Perkins Electronics Co.K972130DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVRFairmontmedicalK945580DSP OPTIONPhilips Medical Systems (Cleveland), Inc.K920793PHILIPS DSI SYSTEM RELEASE 3.2Philips Medical Systems, Inc.K896615CINE CAMERA CONTROL MODEL PK2037Perkins Mfg. Co.K881688DTV-4114 FLUOROSCOPIC TELEVISION CAMERAAdac Laboratories

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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