Densitas Incorporated

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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, Image Processing, Radiological (LLZ) (4)

Premarket Exempt

Clear

densitas® densityAI™ - 00628678950016 Catalog Number :

Device Description : Version 2.7.0

Device Class : 2

Duns Number: 204371579

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

DM-Density - 10627843712753 Catalog Number :

Device Class : 2

Duns Number: 204371579

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

densitasdensity - 10627843712760 Catalog Number :

Device Description : densitasdensity 2.4.1

Device Class : 2

Duns Number: 204371579

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

densitas® densityai™ - 10627843712777 Catalog Number :

Device Description : densitas® densityai™ 2.6.4

Device Class : 2

Duns Number: 204371579

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

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