HealthCCSng

GUDID 07290018016138

NANO-X AI LTD

Radiology DICOM image processing application software
Primary Device ID07290018016138
NIH Device Record Keyc7693e33-7d21-47b5-861f-3f17c85391b4
Commercial Distribution StatusIn Commercial Distribution
Brand NameHealthCCSng
Version Model Number1.1
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 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
GS107290018016138 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAKSystem, X-Ray, Tomography, Computed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-12
Device Publish Date2023-05-04

Devices Manufactured by NANO-X AI LTD

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

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