510(k) K935004
- Device
- Model Alpha Ts-2
- Applicant
- DPA CONSULTING, INC.
- 510(k) number
- K935004
- Product code
- IYB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-12-13
- Date received
- 1993-10-19
- Regulation
- 892.1770
- Classification name
- Tube Mount, X-Ray, Diagnostic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID P ARMSTRONG
- Address
- Box 786 Urbanna VA US 23175 23175
FDA Registration Numbers#
- 3014403439
- 3004756607
- 1450503
- 3010656982
- 3012569470
- 3005920099
- 3008284470
- 9610903
- 3029916061
- 3003768277
- 3005778458
- 2243057
- 9616014
- 3018077344
- 3010789868
- 3011491794
- 3003927316
- 8030233
- 1724615
- 1418964
- 3012624817
- 3003304980
- 3003768251
- 9617251
- 1225677
- 3010583458
- 9613445
- 2428225
- 3006551157
- 3002466018
- 3000126629
- 9616047
- 3007065358
- 3014209556
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IYB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K935123 | SUPERSTAND 300 | Wuestec Medical, Inc. | 1996-03-27 |
| K946261 | MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000 | Scott Imaging Intl., Inc. | 1995-02-15 |
| K941017 | F/C/W TUBESTAND | Acoma Medical Imaging, Inc. | 1994-07-29 |
| K941004 | CTS SYSTEM | Acoma Medical Imaging, Inc. | 1994-07-29 |
| K940442 | MPR-814 | Xri, Inc. | 1994-06-09 |
| K933253 | SUPERSTAND 3000 | Wuestec Medical, Inc. | 1993-08-16 |
| K925716 | BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC | Bennett X-Ray Corp. | 1992-12-17 |
| K925170 | SHIMADZU X-RAY TUBE STAND BH-100 SERIES | Shimadzu Medical Systems | 1992-12-07 |
| K920727 | CEILING TUBE SUPPORT CH-30X | Shimadzu Medical Systems | 1992-04-16 |
| K914944 | BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC | Bennett X-Ray Corp. | 1991-12-02 |
| K914348 | ER-1000 CATHERIZATION C-ARM SYSTEMS | Shimadzu Medical Systems | 1991-11-01 |
| K911563 | INVENTOR RT/EXPLORER TRAUMA UNIT | Continental X-Ray Corp. | 1991-10-23 |
| K912696 | TRAUMA VIEW RAD SYST MODEL #B-TRV/STRET MOBIL TABL | Bennett X-Ray Corp. | 1991-09-16 |
| K900234 | PFM-90 CEILING TUBE SUPPORT | Fischer Imaging Corp. | 1990-02-26 |
| K895188 | SHIMADZU X-RAY TUBE STAND FH-31 | Shimadzu Medical Systems | 1989-09-22 |