Ambra Health

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Digital Image Communications, Radiological (LMD) (1) System, Image Processing, Radiological (LLZ) (1)

Premarket Exempt

No Yes

Clear

Ambra PACS - AMBRHEALTHSOLUTIONS0 Catalog Number :

Device Class : 2

Duns Number: 012054504

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Ambra Health Mobile Application - AMBRMOBILEAPP0 Catalog Number :

Device Description : Mobile Application version of Ambra Health. Not intended for diagnostic purposes.

Device Class : 1

Duns Number: 012054504

Premarket Exempt : Yes

Product Code : LMD

Prescription Use : No

Device Count : 1

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