The following data is part of a premarket notification filed by Accuray Incorporated with the FDA for Delivery Analysis.
Device ID | K143269 |
510k Number | K143269 |
Device Name: | Delivery Analysis |
Classification | System, Planning, Radiation Therapy Treatment |
Applicant | ACCURAY INCORPORATED 1209 DEMING WAY Madison, WI 53717 |
Contact | Keith Picker |
Correspondent | Keith Picker ACCURAY 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 | 2014-11-13 |
Decision Date | 2015-04-14 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
M65810622130 | K143269 | 000 |