PROTURA COUCH SOFTWARE
FDA 510(k) clearance K122201 · decided 2012-08-30
Clearance details
- K-number
- K122201
- Device name
- PROTURA COUCH SOFTWARE
- Applicant
- Med-Tec, Inc. D/B/A Civco Medical Solutions
- Decision
- Substantially Equivalent
- Date received
- 2012-07-25
- Decision date
- 2012-08-30
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- JAI
- Device class
- 2
- Regulation number
- 892.5770
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Orange City, IA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Med-Tec
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Eve Patient Positioner System (K231612) | Leo Cancer Care | 2024-05-07 |
| Z-Robot Patient Positioning System (K182683) | Chinan Biomedical Technology, Inc. | 2019-06-27 |
| Patient Positioning System (K170502) | Forte Automation Systems, Inc. | 2017-04-13 |
| LEONI ORION System (K160518) | Leoni Cia Cable System | 2016-07-14 |
| PROTURA COUCH SOFTWARE (K132084) | Med-Tec, Inc. D/B/A Civco Medical Solutions | 2013-09-26 |
| PATIENT POSITIONING SYSTEM (K122413) | Forte Automation Systems, Inc. | 2012-09-13 |
| EXACTRAC ROBOTICS NOVALIS ROBOTICS (K120520) | Brainlab AG | 2012-06-29 |
| QFIX RADIOTHERAPY CHAIR (K120916) | Wfr/Aquaplast Corp. | 2012-06-20 |
| HEXAPOD EVO RT COUCH TOP (K072898) | Medical Intelligence Medizintechnik GmbH | 2007-10-25 |
| HEXAPOD RT COUCH TOP (K071870) | Medical Intelligence Medizintechnik GmbH | 2007-07-08 |
| MODIFICATION TO HEXAPOD RT COUCH TOP (K062639) | Medical Intelligence Medizintechnik-GmbH-An Elekta | 2006-09-21 |
| AVANZA (K060870) | Mds Nordion | 2006-05-15 |
Recalls involving this device
No recalls on record reference this clearance.