Visitrak, Version 1, Release 1

510(k) Number

K050372 ↗

FDA product code

IYE

Device class

Class II

Regulation

21 CFR Part 892.5050

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code IYE (Accelerator, Linear, Medical).

• LINAC-BASED STEROTACTIC RADIOSURGERY by Radionics Software Applications, Inc.
• Cranial 4Pi Immobilization by Brainlab AG
• MODIFICATION TO: ON-BOARD IMAGER DEVICE by Varian Medical Systems, Inc.
• KLARITY MEDICAL R550-CAEP by Klarity Medical Products, LLC
• GILL-THOMAS-COSMAN(GTC) DENTAL TRAY by Radionics Software Applications, Inc.
• MOSAIQ Oncology Information System by ELEKTA SOLUTIONS AB
• Raycast High Precision Lung Board Solution by Orfit Industries NV
• Klarity Medical R550-HS1 by Klarity Medical Products, LLC
• VARIAN CLINAC 1800S by Varian Assoc., Inc.
• IMAGERT by Impac Medical Systems, Inc.

• Dosimetry Check 5

  Class II

  FDA 510(k) ×4 Active Cleared 24 Apr 2001 GUDID on market

• MillComp 1

  Class II

  FDA 510(k) K011845 Active Cleared 4 Dec 2001 GUDID on market

• RtDosePlan 2

  Class II

  FDA 510(k) K022961 Active Cleared 31 Jan 2003 GUDID on market

• MarkRT 2

  Class II

  FDA 510(k) K050372 Active Cleared 25 Mar 2005 GUDID on market

See all devices from Math Resolutions, LLC →