IYB · Tube Mount, X-Ray, Diagnostic
Radiology · 21 CFR 892.1770 · Class 1
Overview
| Product Code | IYB |
|---|---|
| Device Name | Tube Mount, X-Ray, Diagnostic |
| Regulation | 21 CFR 892.1770 |
| Device Class | Class 1 |
| Review Panel | Radiology |
Identification
A diagnostic x-ray tube mount is a device intended to support and to position the diagnostic x-ray tube housing assembly for a medical radiographic procedure.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 892.9.
Recent Cleared Devices (20 of 40)
Showing 20 most recent of 40 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K935123 | SUPERSTAND 300 | Wuestec Medical, Inc. | Mar 27, 1996 | SESE |
| K946261 | MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000 | Scott Imaging Intl., Inc. | Feb 15, 1995 | SESE |
| K941017 | F/C/W TUBESTAND | Acoma Medical Imaging, Inc. | Jul 29, 1994 | SESE |
| K941004 | CTS SYSTEM | Acoma Medical Imaging, Inc. | Jul 29, 1994 | SESE |
| K940442 | MPR-814 | Xri, Inc. | Jun 9, 1994 | SESE |
| K935004 | MODEL ALPHA TS-2 | Dpa Consulting, Inc. | Dec 13, 1993 | SESE |
| K933253 | SUPERSTAND 3000 | Wuestec Medical, Inc. | Aug 16, 1993 | SESE |
| K925716 | BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC | Bennett X-Ray Corp. | Dec 17, 1992 | SESE |
| K925170 | SHIMADZU X-RAY TUBE STAND BH-100 SERIES | Shimadzu Medical Systems | Dec 7, 1992 | SESE |
| K920727 | CEILING TUBE SUPPORT CH-30X | Shimadzu Medical Systems | Apr 16, 1992 | SESE |
| K914944 | BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC | Bennett X-Ray Corp. | Dec 2, 1991 | SESE |
| K914348 | ER-1000 CATHERIZATION C-ARM SYSTEMS | Shimadzu Medical Systems | Nov 1, 1991 | SESE |
| K911563 | INVENTOR RT/EXPLORER TRAUMA UNIT | Continental X-Ray Corp. | Oct 23, 1991 | SESE |
| K912696 | TRAUMA VIEW RAD SYST MODEL #B-TRV/STRET MOBIL TABL | Bennett X-Ray Corp. | Sep 16, 1991 | SESE |
| K900234 | PFM-90 CEILING TUBE SUPPORT | Fischer Imaging Corp. | Feb 26, 1990 | SESE |
| K895188 | SHIMADZU X-RAY TUBE STAND FH-31 | Shimadzu Medical Systems | Sep 22, 1989 | SESE |
| K893653 | RADIOGRAPHIC CEILING TUBE SUPPORT CTS15 | Fischer Imaging Corp. | Jun 23, 1989 | SESE |
| K893652 | RADIOGRAPHIC FLOOR MOUNTED TUBESTAND FM 60 | Fischer Imaging Corp. | Jun 23, 1989 | SESE |
| K883664 | LUM VASCULAR PROCEDURE SYSTEM #B5200A | General Electric Co. | Nov 7, 1988 | SESE |
| K883864 | RADKOR SFR-70 | Radkor, Inc. | Oct 19, 1988 | SESE |
Top Applicants
- Fischer Imaging Corp. — 5 clearances
- Shimadzu Medical Systems — 4 clearances
- Radkor, Inc. — 3 clearances
- Bennett X-Ray Corp. — 3 clearances
- Wuestec Medical, Inc. — 2 clearances
