HealthPNX

GUDID 07290018016077

NANO-X AI LTD

Radiology DICOM image processing application software
Primary Device ID07290018016077
NIH Device Record Keydc3eebe4-4581-49d2-b6fc-ae6e98242136
Commercial Distribution StatusIn Commercial Distribution
Brand NameHealthPNX
Version Model Number2.0.0
Company DUNS600098228
Company NameNANO-X AI LTD
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
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
GS107290018016077 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QFMRadiological Computer-Assisted Prioritization Software For Lesions

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-03-28
Device Publish Date2020-06-12

Devices Manufactured by NANO-X AI LTD

07290018016145 - HealthOST2023-05-17
07290018016138 - HealthCCSng2023-05-12
07290018016114 - HealthOST2022-08-09
07290018016077 - HealthPNX2022-03-28
07290018016077 - HealthPNX2022-03-28

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