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FDA 510(k)

LEGEND CRF FLUORO AND RAD SYSTEM

K-Number: K993665 · 1999-11-12

ApplicantGe Medical Systems, Inc.
Decision Date1999-11-12
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LEGEND CRF FLUORO AND RAD SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, Inc.. It received FDA 510(k) clearance on 1999-11-12 under 510(k) number K993665. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEGEND CRF FLUORO AND RAD SYSTEM?

LEGEND CRF FLUORO AND RAD SYSTEM is a medical device that received FDA 510(k) clearance on 1999-11-12. The listed applicant is Ge Medical Systems, Inc.. The 510(k) number is K993665.

When did LEGEND CRF FLUORO AND RAD SYSTEM receive FDA 510(k) clearance?

LEGEND CRF FLUORO AND RAD SYSTEM received FDA 510(k) clearance on 1999-11-12, under 510(k) number K993665.

Who is the listed applicant for LEGEND CRF FLUORO AND RAD SYSTEM?

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

What is the FDA product code for LEGEND CRF FLUORO AND RAD SYSTEM?

The FDA product code for LEGEND CRF FLUORO AND RAD SYSTEM is KPR.

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Related Devices (Code: KPR)

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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