Neurophet SCALE PET

FDA 510(k) K221405 · Neurophet., Inc.

Substantially Equivalent

510(k) numberK221405

Submission

Device name
Neurophet SCALE PET
Applicant
Neurophet., Inc.
Seoul, KR
Received
May 16, 2022
Decision date
August 5, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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More from Avara Software

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K261273Neurophet AQUAQIH · Special 05/15/2026SE
K252563Neurophet SCALE PETQIH · Traditional 05/15/2026SE
K252496Neurophet AQUA AD PlusQIH · Traditional 01/29/2026SE
K242215Neurophet AQUA (V3.1)QIH · Traditional 10/25/2024SE
K220437Neurophet AQUALLZ · Traditional 05/10/2023SE

Questions and answers

When was Neurophet SCALE PET cleared by the FDA?

Neurophet SCALE PET (K221405) received a 510(k) decision of Substantially Equivalent on August 5, 2022, 81 days after the submission was received.

What is the product code of K221405?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.