CARBON FIBER CONFORMAL COUCH TOP
FDA 510(k) clearance K973842 · decided 1997-12-05
Clearance details
- K-number
- K973842
- Device name
- CARBON FIBER CONFORMAL COUCH TOP
- Applicant
- Medtec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-10-08
- Decision date
- 1997-12-05
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- IXQ
- Device class
- 2
- Regulation number
- 892.1980
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Orange City, IA, US
- Third-party review
- No
- Expedited review
- No
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| DIAL-A-RAD PORTA RAD TABLE (K913425) | Dial-A-Rad | 1992-11-24 |
| R-MADE HEAD/ARM SUPPORT (K923775) | R-Made, Inc. | 1992-10-20 |
| BUCKY TABLE BK-12 (K920729) | Shimadzu Medical Systems | 1992-04-27 |
| CLINITRON C-10 (K914351) | Ssi Medical Services, Inc. | 1992-02-14 |
| MILITARY RADIOGRAPHIC FLAT TABLE, CAT # T-9130 (K912382) | Continental X-Ray Corp. | 1991-10-10 |
| ECONOMY C-ARM TABLE, MODEL # 056-005 (K904187) | Atomic Products Corp. | 1990-11-29 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CIVCO Pro-Lok Platform, REF MTSBRT002. Firm name on label is CIVCO, Orange City, Iowa Prod recall (Z-3019-2011) | Civco Medical Instruments Inc | 2011-08-15 |
| CIVCO SBRT System, REF MTSBRT001, containing CIVCO Pro-Lok Platform, REF MTSBRT002. Firm n recall (Z-3020-2011) | Civco Medical Instruments Inc | 2011-08-15 |
| CIVCO SBRT System, REF MTSBRT001L, containing CIVCO Pro-Lok Platform, REF MTSBRT002. Firm recall (Z-3021-2011) | Civco Medical Instruments Inc | 2011-08-15 |
| CIVCO Rectangular Extension, REF MTIL6600, Reusable non-sterile extension for use with Uni recall (Z-0394-2011) | Med Tec Inc | 2010-11-16 |
| CIVCO Type-S Extension, REF MTIL6605, Reusable non-sterile extension for use with Universa recall (Z-0395-2011) | Med Tec Inc | 2010-11-16 |
| CIVCO Posifix Extension, REF MTIL6606, Reusable non-sterile extension for use with the Uni recall (Z-0396-2011) | Med Tec Inc | 2010-11-16 |
| Foot Lok Cusion, Part Number MTAFS01, reusable nonsterile (20.3 x 42 x 25.4cm) cushion. recall (Z-1721-2009) | Med Tec Inc | 2009-08-20 |