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FDA 510(k)

CANON X-RAY IMAGE DISTRIBUTOR

K-Number: K853984 · 1985-10-16

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

Device Summary

CANON X-RAY IMAGE DISTRIBUTOR 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 K853984. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CANON X-RAY IMAGE DISTRIBUTOR?

CANON X-RAY IMAGE DISTRIBUTOR 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 K853984.

When did CANON X-RAY IMAGE DISTRIBUTOR receive FDA 510(k) clearance?

CANON X-RAY IMAGE DISTRIBUTOR received FDA 510(k) clearance on 1985-10-16, under 510(k) number K853984.

Who is the listed applicant for CANON X-RAY IMAGE DISTRIBUTOR?

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 IMAGE DISTRIBUTOR?

The FDA product code for CANON X-RAY IMAGE DISTRIBUTOR is JAA.

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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: JAA)

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.

K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging CorporationK251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLCK242488Soteria E-ViewOmega Medical Imaging, LLCK242948Adora DRFi (04550010)Nrt X-Ray A/SK233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech AmericaK233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH

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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