FDA 510(k)

BBX-PET Scanner

K-Number: K210450 · 2021-03-17

Decision Date2021-03-17

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

BBX-PET Scanner is the device name listed in this FDA 510(k) record. The listed applicant is Prescient Imaging, LLC. It received FDA 510(k) clearance on 2021-03-17 under 510(k) number K210450. 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 BBX-PET Scanner?

BBX-PET Scanner is a medical device that received FDA 510(k) clearance on 2021-03-17. The listed applicant is Prescient Imaging, LLC. The 510(k) number is K210450.

When did BBX-PET Scanner receive FDA 510(k) clearance?

BBX-PET Scanner received FDA 510(k) clearance on 2021-03-17, under 510(k) number K210450.

Who is the listed applicant for BBX-PET Scanner?

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

What is the FDA product code for BBX-PET Scanner?

The FDA product code for BBX-PET Scanner is KPS.

Related Devices (Code: KPS)

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.

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.