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FDA 510(k)

SIGNA PET/MR

K-Number: K213709 · 2022-01-20

ApplicantGe Medical Systems, LLC
Decision Date2022-01-20
Product CodeOUO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIGNA PET/MR is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2022-01-20 under 510(k) number K213709. The device is classified under product code OUO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGNA PET/MR?

SIGNA PET/MR is a medical device that received FDA 510(k) clearance on 2022-01-20. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K213709.

When did SIGNA PET/MR receive FDA 510(k) clearance?

SIGNA PET/MR received FDA 510(k) clearance on 2022-01-20, under 510(k) number K213709.

Who is the listed applicant for SIGNA PET/MR?

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

What is the FDA product code for SIGNA PET/MR?

The FDA product code for SIGNA PET/MR is OUO.

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Related Devices (Code: OUO)

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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