KXJ · Table, Radiologic
Radiology · 21 CFR 892.1980 · Class 2
Overview
| Product Code | KXJ |
|---|---|
| Device Name | Table, Radiologic |
| 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 31)
Showing 20 most recent of 31 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K050190 | APOLLO | Villa Sistemi Medicali S.P.A. | Mar 25, 2005 | SESE |
| K963905 | RADIOGRAPHIC ITT TABLE | X-Ray Technologies, Inc. | Nov 12, 1996 | SESE |
| K955414 | XRT 400 | Wuestec Medical, Inc. | Jul 24, 1996 | SESE |
| K951146 | IMAGING TABLE | Septa Corp. | May 4, 1995 | SESE |
| K950068 | CARBON FIBER COUCH INSERT | Medtec, Inc. | Apr 6, 1995 | SESE |
| K950442 | INFRARED EXPOSURE HAND SWITCH | Medical X-Ray Intl., Inc. | Mar 31, 1995 | SESE |
| K940696 | SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5 | Philips Medical Systems North America, Inc. | Mar 16, 1994 | SESE |
| K931724 | ELECTROPHYSIOLOGY (EP) TABLE EP 2000 SERIES | Continental X-Ray Corp. | Jun 14, 1993 | SESE |
| K926407 | MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILM | Nucletron-Oldelft Corp. | Mar 31, 1993 | SESE |
| K922098 | CAG-02A | Toshiba America Medical Systems, In.C | Jul 27, 1992 | SESE |
| K913121 | OMNIFLEX OVERHEAD TUBECRANE CAT.#S-9108/#6713.400 | Continental X-Ray Corp. | Aug 16, 1991 | SESE |
| K883885 | RADKOR, RF-159 | Radkor, Inc. | Oct 19, 1988 | SESE |
| K883155 | RASTIX X-RAY TABLE | Bay X-Ray, Inc. | Sep 6, 1988 | SESE |
| K881700 | RADKOR KOB-84 | Radkor, Inc. | Sep 2, 1988 | SESE |
| K874934 | UNIVERSAL EXAMINATION TABLE | Imatron, Inc. | Jan 19, 1988 | SESE |
| K874639 | REMOTE-CONTROLLED UNIVERSAL DIAG. TABLE RS-100 | Shimadzu Precision Instruments, Inc. | Dec 4, 1987 | SESE |
| K871827 | OMEGA III ANGIOGRAPHIC TABLE, ROTATION & STEPPER | General Electric Co. | Jun 19, 1987 | SESE |
| K862144 | X-MAT | Combined Concepts, Inc. | Jun 25, 1986 | SESE |
| K860620 | SHAMPAINE RADI-OP MODEL 1700RC | Smith & Nephew, Inc. | Apr 8, 1986 | SESE |
| K854328 | MEDEX X-RAY TABLE | Philips Medical Systems (Cleveland), Inc. | Jan 28, 1986 | SESE |
Top Applicants
- Siemens Corp. — 3 clearances
- Continental X-Ray Corp. — 2 clearances
- Philips Medical Systems (Cleveland), Inc. — 2 clearances
- Radkor, Inc. — 2 clearances
- Bay X-Ray, Inc. — 1 clearance
