The following data is part of a premarket notification filed by Med-tec, Inc. D/b/a Civco Medical Solutions with the FDA for Protura Couch Software.
| Device ID | K122201 |
| 510k Number | K122201 |
| Device Name: | PROTURA COUCH SOFTWARE |
| Classification | Couch, Radiation Therapy, Powered |
| Applicant | MED-TEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS 1401 8TH STREET SE Orange City, IA 51041 |
| Contact | Amanda Stahle |
| Correspondent | Amanda Stahle MED-TEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS 1401 8TH STREET SE Orange City, IA 51041 |
| Product Code | JAI |
| CFR Regulation Number | 892.5770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-25 |
| Decision Date | 2012-08-30 |
| Summary: | summary |