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FDA 510(k)

STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY

K-Number: K973206 · 1997-12-04

ApplicantSterling Diagnostic Imaging, Inc.
Decision Date1997-12-04
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY 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 1997-12-04 under 510(k) number K973206. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY?

STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY is a medical device that received FDA 510(k) clearance on 1997-12-04. The listed applicant is Sterling Diagnostic Imaging, Inc.. The 510(k) number is K973206.

When did STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY receive FDA 510(k) clearance?

STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY received FDA 510(k) clearance on 1997-12-04, under 510(k) number K973206.

Who is the listed applicant for STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY?

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 STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY?

The FDA product code for STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY is MQB.

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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 SYSTEMK974423ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAILK972660RAVEN DRY PRINTERK973028HELIOS LASER IMAGER 1417K964250LINX NETWORKING SYSTEM

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Related Devices (Code: MQB)

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.

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, 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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