DeepTek CXR Analyzer

GUDID 08908023670038

DEEPTEK MEDICAL IMAGING PRIVATE LIMITED

Radiology DICOM image processing application software
Primary Device ID08908023670038
NIH Device Record Key381c1dab-e245-4c51-8e15-bed8cbaf6985
Commercial Distribution StatusIn Commercial Distribution
Brand NameDeepTek CXR Analyzer
Version Model Number1.0.0
Company DUNS861402871
Company NameDEEPTEK MEDICAL IMAGING PRIVATE LIMITED
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 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
GS108908023670038 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MYNAnalyzer, Medical Image

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-02
Device Publish Date2025-04-24

Devices Manufactured by DEEPTEK MEDICAL IMAGING PRIVATE LIMITED

08908023670007 - Augmento2025-05-02
08908023670038 - DeepTek CXR Analyzer2025-05-02
08908023670038 - DeepTek CXR Analyzer2025-05-02

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