Neurophet SCALE PET

GUDID 08800130400174

NEUROPHET Inc.

MRI system application software
Primary Device ID08800130400174
NIH Device Record Keyfff547e9-8fde-4e77-b1d4-ff2b42540b61
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeurophet SCALE PET
Version Model Number1.2
Company DUNS694626491
Company NameNEUROPHET Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800130400174 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-29
Device Publish Date2023-06-21

Devices Manufactured by NEUROPHET Inc.

08800130400242 - Neurophet AQUA2025-01-09
08800130400167 - Neurophet AQUA2023-06-29
08800130400174 - Neurophet SCALE PET2023-06-29
08800130400174 - Neurophet SCALE PET2023-06-29

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