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 | K132084 |
| 510k Number | K132084 |
| 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 | 2013-07-05 |
| Decision Date | 2013-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841439111703 | K132084 | 000 |
| 00841439102893 | K132084 | 000 |
| 00841439102930 | K132084 | 000 |
| 00841439110140 | K132084 | 000 |
| 00841439110522 | K132084 | 000 |
| 00841439110539 | K132084 | 000 |
| 00841439110652 | K132084 | 000 |
| 00841439101957 | K132084 | 000 |
| 00841439101964 | K132084 | 000 |
| 00841439101971 | K132084 | 000 |
| 00841439101995 | K132084 | 000 |
| 00841439102732 | K132084 | 000 |
| 00841439102749 | K132084 | 000 |
| 00841439102756 | K132084 | 000 |
| 00841439102763 | K132084 | 000 |
| 00841439102770 | K132084 | 000 |
| 00841439102787 | K132084 | 000 |
| 00841439111376 | K132084 | 000 |
| 00841439102855 | K132084 | 000 |