ECONOMY C-ARM TABLE, MODEL # 056-005
FDA 510(k) clearance K904187 · decided 1990-11-29
Clearance details
- K-number
- K904187
- Device name
- ECONOMY C-ARM TABLE, MODEL # 056-005
- Applicant
- Atomic Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 1990-09-12
- Decision date
- 1990-11-29
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- IXQ
- Device class
- 2
- Regulation number
- 892.1980
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Shirley, NY, 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 |
|---|---|---|
| CARBON FIBER CONFORMAL COUCH TOP (K973842) | Medtec, Inc. | 1997-12-05 |
| MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300 (K960083) | Wuestec Medical, Inc. | 1996-07-24 |
| MED-TEC HAND GRIP (K954225) | Medtec, Inc. | 1995-11-14 |
| EURO, SCST, SCCFT ATLAS RADIOLOGIC TABLES (K946262) | Scott Imaging Intl., Inc. | 1995-02-15 |
| OCTOPAQUE UNIVERSAL (K942916) | Octostop, Inc. | 1994-09-08 |
| ID100 MOBILE FLUOROSCOPIC EXAMINING TABLE (K942190) | Image Diagnostics, Inc. | 1994-08-17 |
| 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 |
| RADIOGRAPHIC TRANSPORT, TRAUMA MODEL 056-230, 235 (K904623) | Atomic Products Corp. | 1990-11-06 |
Recalls involving this device
No recalls on record reference this clearance.