XCISION MEDICAL SYSTEMS, LLC

Address:9176 RED BRANCH RD STE O,Columbia,MD,21045,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, Radiation Therapy, Radionuclide (IWB) (10)

Premarket Exempt

Clear

GammaPod™ - 00850002615005 Catalog Number : XMSGP030A00-0.02

Device Description : Stereotactic Radiotherapy System

Device Class : 2

Duns Number: 788286941

Premarket Exempt : No

Product Code : IWB

Prescription Use : Yes

Device Count : 1

GammaPod™ Treatment Control System - 00850002615012 Catalog Number : XMSGP030A09.06-101

Device Description : TCS Software

Device Class : 2

Duns Number: 788286941

Premarket Exempt : No

Product Code : IWB

Prescription Use : Yes

Device Count : 1

GammaPod™ Treatment Planning System - 00850002615029 Catalog Number : XMSGP030A09.07-001

Device Description : TPS Software

Device Class : 2

Duns Number: 788286941

Premarket Exempt : No

Product Code : IWB

Prescription Use : Yes

Device Count : 1

GammaPod™ Imager Loader and Couch - 00850002615036 Catalog Number : XMSGP030A08.00-0.00

Device Description : Imager Loader and Couch

Device Class : 2

Duns Number: 788286941

Premarket Exempt : No

Product Code : IWB

Prescription Use : Yes

Device Count : 1

GammaPod™ Breast Immobilization and Localization System - 00850002615043 Catalog Number : XMSGP030A10.03-0.01

Device Class : 2

Duns Number: 788286941

Premarket Exempt : No

Product Code : IWB

Prescription Use : Yes

Device Count : 1

GammaPod™ Breast Immobilization and Localization System - 00850002615050 Catalog Number : XMSGP030A10.00-0.04

Device Description : Large

Device Class : 2

Duns Number: 788286941

Premarket Exempt : No

Product Code : IWB

Prescription Use : Yes

Device Count : 1

GammaPod™ Breast Immobilization and Localization System - 00850002615067 Catalog Number : XMSGP030A10.00-0.05

Device Description : Medium

Device Class : 2

Duns Number: 788286941

Premarket Exempt : No

Product Code : IWB

Prescription Use : Yes

Device Count : 1

GammaPod™ Breast Immobilization and Localization System - 00850002615074 Catalog Number : XMSGP030A10.00-0.06

Device Description : Small

Device Class : 2

Duns Number: 788286941

Premarket Exempt : No

Product Code : IWB

Prescription Use : Yes

Device Count : 1

GammaPod™ Breast Immobilization and Localization System - 10850002615088 Catalog Number : XMSGP030A10.05-001

Device Description : Large

Device Class :

Duns Number: 788286941

Premarket Exempt : No

Product Code : IWB

Prescription Use : Yes

Device Count : 20

GammaPod™ Breast Immobilization and Localization System - 10850002615095 Catalog Number : XMSGP030A10.05-002

Device Description : Medium

Device Class :

Duns Number: 788286941

Premarket Exempt : No

Product Code : IWB

Prescription Use : Yes

Device Count : 20

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