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FDA 510(k)

PLATINUM READING, REVIEW & ANALYSIS WORKSTATION

K-Number: K981217 · 1998-06-18

ApplicantGE Medical Systems
Decision Date1998-06-18
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PLATINUM READING, REVIEW & ANALYSIS WORKSTATION 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 1998-06-18 under 510(k) number K981217. 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 PLATINUM READING, REVIEW & ANALYSIS WORKSTATION?

PLATINUM READING, REVIEW & ANALYSIS WORKSTATION is a medical device that received FDA 510(k) clearance on 1998-06-18. The listed applicant is GE Medical Systems. The 510(k) number is K981217.

When did PLATINUM READING, REVIEW & ANALYSIS WORKSTATION receive FDA 510(k) clearance?

PLATINUM READING, REVIEW & ANALYSIS WORKSTATION received FDA 510(k) clearance on 1998-06-18, under 510(k) number K981217.

Who is the listed applicant for PLATINUM READING, REVIEW & ANALYSIS WORKSTATION?

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 PLATINUM READING, REVIEW & ANALYSIS WORKSTATION?

The FDA product code for PLATINUM READING, REVIEW & ANALYSIS WORKSTATION is 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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