IXQ · Table, Radiographic, Stationary Top
Radiology · 21 CFR 892.1980 · Class 2
Overview
| Product Code | IXQ |
|---|---|
| Device Name | Table, Radiographic, Stationary Top |
| Regulation | 21 CFR 892.1980 |
| Device Class | Class 2 |
| Review Panel | Radiology |
Identification
A radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table may be fixed or tilting and may be electrically powered.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
Recent Cleared Devices (20 of 27)
Showing 20 most recent of 27 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K973842 | CARBON FIBER CONFORMAL COUCH TOP | Medtec, Inc. | Dec 5, 1997 | SESE |
| K960083 | MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300 | Wuestec Medical, Inc. | Jul 24, 1996 | SESE |
| K954225 | MED-TEC HAND GRIP | Medtec, Inc. | Nov 14, 1995 | SESE |
| K946262 | EURO, SCST, SCCFT ATLAS RADIOLOGIC TABLES | Scott Imaging Intl., Inc. | Feb 15, 1995 | SESE |
| K942916 | OCTOPAQUE UNIVERSAL | Octostop, Inc. | Sep 8, 1994 | SESE |
| K942190 | ID100 MOBILE FLUOROSCOPIC EXAMINING TABLE | Image Diagnostics, Inc. | Aug 17, 1994 | SESE |
| K913425 | DIAL-A-RAD PORTA RAD TABLE | Dial-A-Rad | Nov 24, 1992 | SESE |
| K923775 | R-MADE HEAD/ARM SUPPORT | R-Made, Inc. | Oct 20, 1992 | SESE |
| K920729 | BUCKY TABLE BK-12 | Shimadzu Medical Systems | Apr 27, 1992 | SESE |
| K914351 | CLINITRON C-10 | Ssi Medical Services, Inc. | Feb 14, 1992 | SESE |
| K912382 | MILITARY RADIOGRAPHIC FLAT TABLE, CAT # T-9130 | Continental X-Ray Corp. | Oct 10, 1991 | SESE |
| K904187 | ECONOMY C-ARM TABLE, MODEL # 056-005 | Atomic Products Corp. | Nov 29, 1990 | SESE |
| K904623 | RADIOGRAPHIC TRANSPORT, TRAUMA MODEL 056-230, 235 | Atomic Products Corp. | Nov 6, 1990 | SESE |
| K903160 | LIEBEL-FLARSHEIM SERIES 8000 BUCKY,W/NON SIZE SENS | Continental X-Ray Corp. | Aug 8, 1990 | SESE |
| K893690 | SUPER SPEED POTTER-BUCKY (ESO5-110 & 220) | Hofmann X-Ray of America, Inc. | Jul 20, 1989 | SESE |
| K892196 | RADKOR TS10-B | Radkor, Inc. | Apr 26, 1989 | SESE |
| K873702 | REI-38 RADIOGRAPHIC TABLE | Radiological Engineering, Inc. | Apr 22, 1988 | SESE |
| K873849 | ALTAIREX BUCKY/CASSETTE TRAY COMBINATION | Altairex Manufacturing, Inc. | Oct 28, 1987 | SESE |
| K862825 | HI-LO ELEVATOR FLAT TABLE | Garrels X-Ray Products, Inc. | Sep 4, 1986 | SESE |
| K862826 | ITT INTERGRATED TABLE AND TUBESTAND | Garrels X-Ray Products, Inc. | Aug 1, 1986 | SESE |
Top Applicants
- Tecnomed, Inc. — 2 clearances
- Medtec, Inc. — 2 clearances
- Garrels X-Ray Products, Inc. — 2 clearances
- Continental X-Ray Corp. — 2 clearances
- Atomic Products Corp. — 2 clearances
