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FDA 510(k)

IIRAD DIRECTRAY OPERATOR CONSOLE

K-Number: K980970 · 1998-06-08

ApplicantSterling Diagnostic Imaging, Inc.
Decision Date1998-06-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IIRAD DIRECTRAY OPERATOR CONSOLE 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 1998-06-08 under 510(k) number K980970. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IIRAD DIRECTRAY OPERATOR CONSOLE?

IIRAD DIRECTRAY OPERATOR CONSOLE is a medical device that received FDA 510(k) clearance on 1998-06-08. The listed applicant is Sterling Diagnostic Imaging, Inc.. The 510(k) number is K980970.

When did IIRAD DIRECTRAY OPERATOR CONSOLE receive FDA 510(k) clearance?

IIRAD DIRECTRAY OPERATOR CONSOLE received FDA 510(k) clearance on 1998-06-08, under 510(k) number K980970.

Who is the listed applicant for IIRAD DIRECTRAY OPERATOR CONSOLE?

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 IIRAD DIRECTRAY OPERATOR CONSOLE?

The FDA product code for IIRAD DIRECTRAY OPERATOR CONSOLE is LLZ.

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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.

K980220IISYS PACS SYSTEMK974423ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAILK973206STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHYK972660RAVEN DRY PRINTERK973028HELIOS LASER IMAGER 1417K964250LINX NETWORKING SYSTEM

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Related Devices (Code: LLZ)

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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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