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FDA 510(k)

INTEGRATED DIAGNOSTIC SYSTEM W/ADD'L OPTIONS

K-Number: K902428 · 1990-11-19

ApplicantGE Medical Systems
Decision Date1990-11-19
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INTEGRATED DIAGNOSTIC SYSTEM W/ADD'L OPTIONS is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems. It received FDA 510(k) clearance on 1990-11-19 under 510(k) number K902428. 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 INTEGRATED DIAGNOSTIC SYSTEM W/ADD'L OPTIONS?

INTEGRATED DIAGNOSTIC SYSTEM W/ADD'L OPTIONS is a medical device that received FDA 510(k) clearance on 1990-11-19. The listed applicant is GE Medical Systems. The 510(k) number is K902428.

When did INTEGRATED DIAGNOSTIC SYSTEM W/ADD'L OPTIONS receive FDA 510(k) clearance?

INTEGRATED DIAGNOSTIC SYSTEM W/ADD'L OPTIONS received FDA 510(k) clearance on 1990-11-19, under 510(k) number K902428.

Who is the listed applicant for INTEGRATED DIAGNOSTIC SYSTEM W/ADD'L OPTIONS?

The FDA 510(k) record lists GE Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTEGRATED DIAGNOSTIC SYSTEM W/ADD'L OPTIONS?

The FDA product code for INTEGRATED DIAGNOSTIC SYSTEM W/ADD'L OPTIONS is LLZ.

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Other records listing GE Medical Systems as applicant

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Related Devices (Code: LLZ)

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.

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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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