Brit Systems, LLC

Address:13737 Noel Rd., Ste 120,DALLAS,TX,75240,US

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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) (10) Device, Digital Image Storage, Radiological (LMB) (9)

Premarket Exempt

No Yes

Clear

Roentgen Works - 00850631008407 Catalog Number :

Device Description : Roentgen Works 5.0.4 is a PACS, RIS, and Viewer.

Device Class : 1

Duns Number: 941442410

Premarket Exempt : No

Product Code : LMB, LLZ

Prescription Use : No

Device Count : 1

Roentgen Works - 00850631008414 Catalog Number :

Device Description : Roentgen Works 5.0.5 is a PACS, RIS, and Viewer.

Device Class : 1

Duns Number: 941442410

Premarket Exempt : No

Product Code : LMB, LLZ

Prescription Use : No

Device Count : 1

Roentgen Works - 00850631008421 Catalog Number :

Device Description : Roentgen Works 5.1.0 is a PACS, RIS, and Viewer.

Device Class : 1

Duns Number: 941442410

Premarket Exempt : No

Product Code : LMB, LLZ

Prescription Use : No

Device Count : 1

Roentgen Works - 00850631008438 Catalog Number :

Device Description : Roentgen Works 5.1.1 is a PACS, RIS, and Viewer.

Device Class : 1

Duns Number: 941442410

Premarket Exempt : No

Product Code : LMB, LLZ

Prescription Use : No

Device Count : 1

Roentgen Works - 00850631008445 Catalog Number :

Device Description : Roentgen Works 5.1.2 is a PACS, RIS, and Viewer.

Device Class : 1

Duns Number: 941442410

Premarket Exempt : No

Product Code : LMB, LLZ

Prescription Use : No

Device Count : 1

Roentgen Works - 00850631008452 Catalog Number :

Device Description : Roentgen Works 5.1.3 is a PACS, RIS, and Viewer.

Device Class : 1

Duns Number: 941442410

Premarket Exempt : No

Product Code : LMB, LLZ

Prescription Use : No

Device Count : 1

Roentgen Works - 00850631008469 Catalog Number :

Device Description : Roentgen Works 5.2.0 is a PACS, RIS, and Viewer.

Device Class : 1

Duns Number: 941442410

Premarket Exempt : No

Product Code : LMB, LLZ

Prescription Use : No

Device Count : 1

Roentgen Works - 00850631008476 Catalog Number :

Device Description : Roentgen Works 5.2.1 is a PACS, RIS, and Viewer.

Device Class : 1

Duns Number: 941442410

Premarket Exempt : No

Product Code : LMB, LLZ

Prescription Use : No

Device Count : 1

Roentgen Works - 00850631008483 Catalog Number :

Device Description : Roentgen Works 5.3.0 is a PACS, RIS, and Viewer.

Device Class : 1

Duns Number: 941442410

Premarket Exempt : No

Product Code : LMB, LLZ

Prescription Use : No

Device Count : 1

BRIT Vision - 00850631008490 Catalog Number :

Device Description : BRIT Vision 4.1.1

Device Class : 2

Duns Number: 941442410

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

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