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FDA 510(k)

Neurophet SCALE PET

K-Number: K221405 · 2022-08-05

ApplicantNeurophet., Inc.
Decision Date2022-08-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Neurophet SCALE PET is the device name listed in this FDA 510(k) record. The listed applicant is Neurophet., Inc.. It received FDA 510(k) clearance on 2022-08-05 under 510(k) number K221405. 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 Neurophet SCALE PET?

Neurophet SCALE PET is a medical device that received FDA 510(k) clearance on 2022-08-05. The listed applicant is Neurophet., Inc.. The 510(k) number is K221405.

When did Neurophet SCALE PET receive FDA 510(k) clearance?

Neurophet SCALE PET received FDA 510(k) clearance on 2022-08-05, under 510(k) number K221405.

Who is the listed applicant for Neurophet SCALE PET?

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

What is the FDA product code for Neurophet SCALE PET?

The FDA product code for Neurophet SCALE PET is LLZ.

Other records listing Neurophet., Inc. 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.

K261273Neurophet AQUAK252563Neurophet SCALE PETK252496Neurophet AQUA AD PlusK242215Neurophet AQUA (V3.1)K220437Neurophet AQUA

Related Devices (Code: LLZ)

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.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

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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