ChestView US

GUDID 03770020839092

GLEAMER

Radiological PACS software
Primary Device ID03770020839092
NIH Device Record Keyb6b49639-de84-413e-bcee-6cbee7eda0a1
Commercial Distribution StatusIn Commercial Distribution
Brand NameChestView US
Version Model Number1.0.X
Company DUNS281142375
Company NameGLEAMER
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
GS103770020839092 [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 Date2025-04-10
Device Publish Date2025-04-02

Devices Manufactured by GLEAMER

03770020839092 - ChestView US2025-04-10
03770020839092 - ChestView US2025-04-10
03770020839108 - BoneMetrics US2025-04-10
03770020839085 - BoneView2023-03-24
03770020839009 - BoneView2022-04-28

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