IYB — Tube Mount, X-Ray, Diagnostic Class I
FDA product code IYB covers "Tube Mount, X-Ray, Diagnostic", a Class I medical device regulated under 21 CFR 892.1770. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IYB
- Device Class
- Class I
- Regulation Number
- 892.1770
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K935123 | wuestec medical | SUPERSTAND 300 | March 27, 1996 |
| K946261 | scott imaging intl | MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000 | February 15, 1995 |
| K941017 | acoma medical imaging | F/C/W TUBESTAND | July 29, 1994 |
| K941004 | acoma medical imaging | CTS SYSTEM | July 29, 1994 |
| K940442 | xri | MPR-814 | June 9, 1994 |
| K935004 | dpa consulting | MODEL ALPHA TS-2 | December 13, 1993 |
| K933253 | wuestec medical | SUPERSTAND 3000 | August 16, 1993 |
| K925716 | bennett x-ray | BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC | December 17, 1992 |
| K925170 | shimadzu medical systems | SHIMADZU X-RAY TUBE STAND BH-100 SERIES | December 7, 1992 |
| K920727 | shimadzu medical systems | CEILING TUBE SUPPORT CH-30X | April 16, 1992 |
| K914944 | bennett x-ray | BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC | December 2, 1991 |
| K914348 | shimadzu medical systems | ER-1000 CATHERIZATION C-ARM SYSTEMS | November 1, 1991 |
| K911563 | continental x-ray | INVENTOR RT/EXPLORER TRAUMA UNIT | October 23, 1991 |
| K912696 | bennett x-ray | TRAUMA VIEW RAD SYST MODEL #B-TRV/STRET MOBIL TABL | September 16, 1991 |
| K900234 | fischer imaging | PFM-90 CEILING TUBE SUPPORT | February 26, 1990 |
| K895188 | shimadzu medical systems | SHIMADZU X-RAY TUBE STAND FH-31 | September 22, 1989 |
| K893652 | fischer imaging | RADIOGRAPHIC FLOOR MOUNTED TUBESTAND FM 60 | June 23, 1989 |
| K893653 | fischer imaging | RADIOGRAPHIC CEILING TUBE SUPPORT CTS15 | June 23, 1989 |
| K883664 | general electric | LUM VASCULAR PROCEDURE SYSTEM #B5200A | November 7, 1988 |
| K883864 | radkor | RADKOR SFR-70 | October 19, 1988 |