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FDA 510(k)

Neurophet SCALE PET

K-Number: K252563 · 2026-05-15

ApplicantNeurophet., Inc.
Decision Date2026-05-15
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Neurophet SCALE PET is a medical device manufactured by Neurophet., Inc.. It received FDA 510(k) clearance on 2026-05-15 under approval number K252563. The device is classified under product code QIH. 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 2026-05-15. It is manufactured by Neurophet., Inc.. The 510(k) number is K252563.

When was Neurophet SCALE PET approved by the FDA?

Neurophet SCALE PET received FDA 510(k) clearance on 2026-05-15, under approval number K252563.

What company makes Neurophet SCALE PET?

Neurophet SCALE PET is manufactured by Neurophet., Inc..

What is the FDA product code for Neurophet SCALE PET?

The FDA product code for Neurophet SCALE PET is QIH.

Other Devices by Neurophet., Inc.

K261273Neurophet AQUA

Related Devices (Code: QIH)

K261273Neurophet AQUANeurophet., Inc. K254120SubtleHD-CT (1.x)Subtle Medical, Inc. K261289UNiD™ Spine Analyzer (SW3002)Medicrea International S.A.S. (Medtronic) K260032MorphBeauBrain Healthcare, Inc. K254189Synapse 3D Base Tools (V7.2)Fujifilm Corporation K254184syngo Application SoftwareSiemens Medical Solutions USA, 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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