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FDA 510(k)

ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL

K-Number: K974423 · 1997-12-22

ApplicantSterling Diagnostic Imaging, Inc.
Decision Date1997-12-22
Product CodeEAM
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL is the device name listed in this FDA 510(k) record. The listed applicant is Sterling Diagnostic Imaging, Inc.. It received FDA 510(k) clearance on 1997-12-22 under 510(k) number K974423. The device is classified under product code EAM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL?

ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL is a medical device that received FDA 510(k) clearance on 1997-12-22. The listed applicant is Sterling Diagnostic Imaging, Inc.. The 510(k) number is K974423.

When did ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL receive FDA 510(k) clearance?

ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL received FDA 510(k) clearance on 1997-12-22, under 510(k) number K974423.

Who is the listed applicant for ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL?

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

What is the FDA product code for ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL?

The FDA product code for ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL is EAM.

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Other records listing Sterling Diagnostic Imaging, 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.

K980970IIRAD DIRECTRAY OPERATOR CONSOLEK980220IISYS PACS SYSTEMK973206STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHYK972660RAVEN DRY PRINTERK973028HELIOS LASER IMAGER 1417K964250LINX NETWORKING SYSTEM

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Related Devices (Code: EAM)

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.

K963913MD100 & MM150Konica Medical Corp.K954161JPI INTENSIFYING SCREENJpi Healthcare Co, Ltd.K943822FUJI UM MAMMO SERIES INTENSIFY SCREENS:Fujifilm Medical System U.S.A., Inc.K943821KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPECFujifilm Medical System U.S.A., Inc.K943823FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12Fujifilm Medical System U.S.A., Inc.K942235KYOKKO GREEN SERIES INTENSIFYING SCREENSFujifilm Medical System U.S.A., 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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