The following data is part of a premarket notification filed by Tomotherapy Incorporated with the FDA for Modification To Hi-art Treatment System.
Device ID | K082005 |
510k Number | K082005 |
Device Name: | MODIFICATION TO HI-ART TREATMENT SYSTEM |
Classification | System, Planning, Radiation Therapy Treatment |
Applicant | TOMOTHERAPY INCORPORATED 1209 DEMING WAY Madison, WI 53717 |
Contact | Robert Bovy |
Correspondent | Robert Bovy TOMOTHERAPY INCORPORATED 1209 DEMING WAY Madison, WI 53717 |
Product Code | MUJ |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-07-14 |
Decision Date | 2008-08-25 |
Summary: | summary |