MODEL ALPHA TS-2
FDA 510(k) clearance K935004 · decided 1993-12-13
Clearance details
- K-number
- K935004
- Device name
- MODEL ALPHA TS-2
- Applicant
- Dpa Consulting, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-10-19
- Decision date
- 1993-12-13
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- IYB
- Device class
- 1
- Regulation number
- 892.1770
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Urbanna, VA, 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 |
|---|---|---|
| SUPERSTAND 300 (K935123) | Wuestec Medical, Inc. | 1996-03-27 |
| MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000 (K946261) | Scott Imaging Intl., Inc. | 1995-02-15 |
| CTS SYSTEM (K941004) | Acoma Medical Imaging, Inc. | 1994-07-29 |
| F/C/W TUBESTAND (K941017) | Acoma Medical Imaging, Inc. | 1994-07-29 |
| MPR-814 (K940442) | Xri, Inc. | 1994-06-09 |
| SUPERSTAND 3000 (K933253) | Wuestec Medical, Inc. | 1993-08-16 |
| BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC (K925716) | Bennett X-Ray Corp. | 1992-12-17 |
| SHIMADZU X-RAY TUBE STAND BH-100 SERIES (K925170) | Shimadzu Medical Systems | 1992-12-07 |
| CEILING TUBE SUPPORT CH-30X (K920727) | Shimadzu Medical Systems | 1992-04-16 |
| BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC (K914944) | Bennett X-Ray Corp. | 1991-12-02 |
| ER-1000 CATHERIZATION C-ARM SYSTEMS (K914348) | Shimadzu Medical Systems | 1991-11-01 |
| INVENTOR RT/EXPLORER TRAUMA UNIT (K911563) | Continental X-Ray Corp. | 1991-10-23 |
Recalls involving this device
No recalls on record reference this clearance.