PATIENT POSITIONING SYSTEM
FDA 510(k) clearance K122413 · decided 2012-09-13
Clearance details
- K-number
- K122413
- Device name
- PATIENT POSITIONING SYSTEM
- Applicant
- Forte Automation Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-08-08
- Decision date
- 2012-09-13
- 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
- Machesney Park, IL, US
- Third-party review
- No
- Expedited review
- No
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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 |
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| PROTURA COUCH SOFTWARE (K122201) | Med-Tec, Inc. D/B/A Civco Medical Solutions | 2012-08-30 |
| 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.