syngo VSim

syngo VSim - 10830856

Device Description

An application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.

Environmental Conditions

Handling Environment Atmospheric Pressure - KiloPascal

106.00
70.00

Handling Environment Humidity - Percent (%) Relative Humidity

90.00
10.00

Handling Environment Temperature - Degrees Celsius

50.00
-20.00

Storage Environment Atmospheric Pressure - KiloPascal

106.00
70.00

Storage Environment Humidity - Percent (%) Relative Humidity

90.00
10.00

Storage Environment Temperature - Degrees Celsius

50.00
-20.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: MUJ

Device Name: System, Planning, Radiation Therapy Treatment

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: RA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 892.5050

Third Party Flag: N

Medical Specialty: RA

Device Identifiers

Device Id: 04056869013077

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A