IXR · Table, Radiographic, Tilting
Radiology · 21 CFR 892.1980 · Class 2
Overview
| Product Code | IXR |
|---|---|
| Device Name | Table, Radiographic, Tilting |
| 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 77)
Showing 20 most recent of 77 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K000412 | VISION R/F TILTING TABLE | Villa Sistemi Medicali S.P.A. | Apr 24, 2000 | SESE |
| K973039 | LEGACY/LEGACY-D TABLE | GE Medical Systems | Oct 16, 1997 | SESE |
| K971128 | CAP-35B III/CINE 275 | Jamieson Film Co. | Apr 28, 1997 | SESE |
| K970640 | PHILIPS EASY DIAGNOST | Philips Medical Systems North America, Inc. | Mar 21, 1997 | SESE |
| K965105 | ELECTROPHYSIOLOGY TILT TABLE MODEL #9660 | U.S. Imaging Tables, Inc. | Jan 30, 1997 | SESE |
| K965096 | FLUOROVIEW SERIES FLUOROSCOPIC TABLES | U.S. Imaging Tables, Inc. | Jan 27, 1997 | SESE |
| K963851 | TILTING RADIOGRAPHIC TABLE (REMOTE) | Acoma Medical Imaging, Inc. | Jan 23, 1997 | SESE |
| K961022 | TANGENT VI TABLE | Fischer Imaging Corp. | May 3, 1996 | SESE |
| K954356 | COMPAX 90/15E | General Electric Co. | Oct 7, 1995 | SESE |
| K953557 | SURGICAL C-ARM TABLE, 9610 | U.S. Imaging Tables, Inc. | Sep 26, 1995 | SESE |
| K953556 | VACS TABLE, 9650 | U.S. Imaging Tables, Inc. | Sep 26, 1995 | SESE |
| K951176 | KOORDINAT M | Siemens Medical Solutions USA, Inc. | Apr 20, 1995 | SESE |
| K950981 | ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650 | Biodex Medical Systems, Inc. | Apr 3, 1995 | SESE |
| K950402 | CORSINI 9090 | C.A.T. DI Corsini G. & C. Spa | Mar 31, 1995 | SESE |
| K945842 | MOBILIX MOBILE X-RAY TABLE | GE Medical Systems | Jan 18, 1995 | SESE |
| K943581 | HYDRADJUST IV UROLOGICAL TABLE | Mallinckrodt Group, Inc. | Jan 4, 1995 | SESE |
| K944987 | URO - ELITE TABLE ACCESSORIES | Philips Medical Systems (Cleveland), Inc. | Nov 30, 1994 | SESE |
| K935444 | OCTOSTOP(R) CHAIR (NEW MODEL | Octostop, Inc. | Sep 2, 1994 | SESE |
| K940721 | CLINIX VP 4 TABLE | Philips Medical Systems (Cleveland), Inc. | May 3, 1994 | SESE |
| K934574 | MODEL MPFT-01, GENESIS | International Medical Designs, Inc. | Mar 4, 1994 | SESE |
Top Applicants
- Fischer Imaging Corp. — 8 clearances
- Shimadzu Medical Systems — 7 clearances
- U.S. Imaging Tables, Inc. — 4 clearances
- Xre Corp. — 3 clearances
- Tri W-G, Inc. — 3 clearances
