The following data is part of a premarket notification filed by Computerized Medical Systems, Inc. with the FDA for Atlas-based Autosegmentation.
| Device ID | K080799 |
| 510k Number | K080799 |
| Device Name: | ATLAS-BASED AUTOSEGMENTATION |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | COMPUTERIZED MEDICAL SYSTEMS, INC. 1145 CORPORATE LAKE DR. St. Louis, MO 63132 -1716 |
| Contact | Kathryn Stinson |
| Correspondent | Kathryn Stinson COMPUTERIZED MEDICAL SYSTEMS, INC. 1145 CORPORATE LAKE DR. St. Louis, MO 63132 -1716 |
| Product Code | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-21 |
| Decision Date | 2008-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858164002039 | K080799 | 000 |