FDA 510(k)

PET Digital Gating

K-Number: K180318 · 2018-04-11

Decision Date2018-04-11

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

PET Digital Gating 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 2018-04-11 under 510(k) number K180318. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PET Digital Gating?

PET Digital Gating is a medical device that received FDA 510(k) clearance on 2018-04-11. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K180318.

When did PET Digital Gating receive FDA 510(k) clearance?

PET Digital Gating received FDA 510(k) clearance on 2018-04-11, under 510(k) number K180318.

Who is the listed applicant for PET Digital Gating?

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 PET Digital Gating?

The FDA product code for PET Digital Gating is KPS.

Other records listing Ge Medical Systems, LLC as applicant

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.