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FDA 510(k)

IISYS PACS SYSTEM

K-Number: K980220 · 1998-02-13

ApplicantSterling Diagnostic Imaging, Inc.
Decision Date1998-02-13
Product CodeLMD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IISYS PACS SYSTEM 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 1998-02-13 under 510(k) number K980220. The device is classified under product code LMD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IISYS PACS SYSTEM?

IISYS PACS SYSTEM is a medical device that received FDA 510(k) clearance on 1998-02-13. The listed applicant is Sterling Diagnostic Imaging, Inc.. The 510(k) number is K980220.

When did IISYS PACS SYSTEM receive FDA 510(k) clearance?

IISYS PACS SYSTEM received FDA 510(k) clearance on 1998-02-13, under 510(k) number K980220.

Who is the listed applicant for IISYS PACS SYSTEM?

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 IISYS PACS SYSTEM?

The FDA product code for IISYS PACS SYSTEM is LMD.

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Other records listing Sterling Diagnostic Imaging, Inc. as applicant

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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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