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.
Cleared Devices (77)
| 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 |
| K931563 | SPECTRUM MARK I SPECIAL PROCEDURES TABLE | Spectrum X-Ray Corp. | Aug 23, 1993 | SESE |
| K924326 | ARTHRODYN 45 DEGREE X-RAY TABLE | Arthrodyn, Inc. | Apr 8, 1993 | SESE |
| K925175 | SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-200 30/90 | Shimadzu Medical Systems | Nov 27, 1992 | SESE |
| K922591 | UROLOGICAL C-ARM TABLE, MODEL #056-450 | Biodan Medical Systems, Ltd. | Nov 27, 1992 | SESE |
| K922364 | DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST | Toshiba America Medical Systems, In.C | Sep 4, 1992 | SESE |
| K920726 | UROLOGICAL X-RAY TABLE HS-10A | Shimadzu Medical Systems | May 29, 1992 | SESE |
| K920728 | X-RAY DIAGNOSTIC TABLE YSF-100 | Shimadzu Medical Systems | May 28, 1992 | SESE |
| K920742 | HYDRAJUST IV UROLOGICAL TABLE | Mallinckrodt Group, Inc. | Apr 27, 1992 | SESE |
| K920722 | X-RAY DIAGNOSTIC TABLE YSF-200-30-90 | Shimadzu Medical Systems | Apr 13, 1992 | SESE |
| K914417 | MEDIQUIP I.A. FIELD CONV KIT/AMSCO 2080 SER TABLE | Med-Vac, Inc. | Feb 27, 1992 | SESE |
| K912996 | MODIF TOP DRIVE BOARD CXT-90 90/90 DIAG TILT TABLE | Continental X-Ray Corp. | Feb 3, 1992 | SESE |
| K915853 | TANGENT V | Fischer Imaging Corp. | Jan 24, 1992 | SESE |
| K914165 | X-RAY TABLE | Siemens Medical Solutions USA, Inc. | Nov 5, 1991 | SESE |
| K912741 | ELITE R 90/15 | Fischer Imaging Corp. | Oct 4, 1991 | SESE |
| K913147 | SHIMADZU MULTI-DIRECTIONAL DIAGNOSTIC TABLE VS-100 | Shimadzu Medical Systems | Sep 19, 1991 | SESE |
| K910838 | TREATMENT TABLE | Tri W-G, Inc. | Aug 7, 1991 | SESE |
| K912586 | TANGENT IV | Fischer Imaging Corp. | Aug 2, 1991 | SESE |
| K911098 | PHILIPS URO DIAGNOST MRF | Philips Medical Systems, Inc. | Jul 3, 1991 | SESE |
| K911267 | RADIOGRAPHIC/FLUOROSCOPIC TABLE MODEL 9004 | Tri W-G, Inc. | Apr 3, 1991 | SESE |
| K905265 | 620 FLUOROSCOPIC TABLE, TILT OR POWER MEDICAL TAB | Tri W-G, Inc. | Jan 23, 1991 | SESE |
| K905501 | ELITE 5000 | Fischer Imaging Corp. | Jan 18, 1991 | SESE |
| K905153 | REMOTE CONTROLLED X-RAY DIAGNOSTIC RS-110 | Shimadzu Medical Systems | Dec 11, 1990 | SESE |
| K905152 | REMOTE CONTROLLED X-RAY DIAG. RSZ-200 | Shimadzu Medical Systems | Dec 11, 1990 | SESE |
| K901654 | MTT 90 UNIVERSAL REMOTE-CONTROLLED X-RAY TABLE | Imt America, Inc. | Nov 23, 1990 | SESE |
| K902989 | G.E. MONITROL 90 AND G.E. MONITROL 15 | Electromek Diagnostic Systems, Inc. | Oct 29, 1990 | SESE |
| K903422 | MT-15 RADIOGRAPHIC/FLUOROSCOPIC TILT TABLE | Imt America, Inc. | Sep 4, 1990 | SESE |
| K903395 | UROMAT 2000 | Pausch Corp. | Aug 30, 1990 | SESE |
| K896583 | F.A.S.T. TABLE | Oec-Diasonics, Inc. | Mar 1, 1990 | SESE |
| K896119 | RMS 90/15 RADIOGRAPHIC/FLUOROSCOPIC TILTING TABLE | Rms Div. | Nov 27, 1989 | SESE |
| K896324 | ELITE 1500 RADIOGRAPHIC TILTING TABLE | Rms Div. | Nov 21, 1989 | SESE |
| K893673 | RMS 180 | Fischer Imaging Corp. | Jul 20, 1989 | SESE |
| K892226 | TEC 6340 90/15 RADIOGRAPHIC/FLUOROSCOPIC TABLE | Tecnomed, Inc. | Apr 26, 1989 | SESE |
| K884531 | BETA 90/50 MOBILE IMAGING TABLE | Beta Medical Products Co. | Jan 11, 1989 | SESE |
| K883863 | GENESIS 180 | Fischer Imaging Corp. | Oct 21, 1988 | SESE |
| K883162 | TELESTATIX X-RAY TABLE | Bay X-Ray, Inc. | Sep 6, 1988 | SESE |
| K883153 | UNDISTAT WITH EXPLORATOR 35 (UCS 35E) | Bay X-Ray, Inc. | Sep 6, 1988 | SESE |
| K882019 | SMS 90-15 R&F TABLE AND SMS 14 SPOT FILM DEVICE | General Electric Co. | May 31, 1988 | SESE |
| K880529 | CEILING MOUNTED TILTING TABLE TANGENT III | Fischer Imaging Corp. | Mar 3, 1988 | SESE |
| K874114 | TRAUMA TABLE II | Xre Corp. | Nov 16, 1987 | SESE |
| K874113 | OMNI DIAGNOST | Xre Corp. | Nov 16, 1987 | SESE |
| K870707 | PENTAMAX 1 MODEL B TABLE SYSTEM | Spectrum X-Ray Corp. | May 14, 1987 | SESE |
| K854478 | REI-90/90 RADIOGRAPHIC TABLE | Radiological Engineering, Inc. | Apr 17, 1986 | SESE |
| K860913 | SIREGRAPH D | Siemens Medical Solutions USA, Inc. | Apr 1, 1986 | SESE |
| K854486 | TABLE,RADIOGRAPHIC-FLUOROSCOPIC,TOMOGRAPHIC,REMOTE | Absolute X-Ray Corp. | Jan 10, 1986 | SESE |
| K854085 | OMNI PLANE SYSTEM | Xre Corp. | Oct 28, 1985 | SESE |
| K853175 | REI-90/15 | Radiological Engineering, Inc. | Oct 10, 1985 | SESE |
| K850948 | TILTING TABLE RADIOGRAPHIC A9006 TOMOJUPITER | D&R X-Ray Products, Inc. | Apr 10, 1985 | SESE |
| K843926 | PRESTILIX 1690 | Cgr Medical Corp. | Dec 17, 1984 | SESE |
| K840227 | UROLIX-3 UROLOGICAL TABLE | Medicor USA , Ltd. | Mar 23, 1984 | SESE |
| K840226 | MOTOR TILTED EXAM. TABLE UV-56 | Medicor USA , Ltd. | Mar 16, 1984 | SESE |
| K792645 | TRIOSKOP | Siemens Corp. | Jan 28, 1980 | SESE |
| K792326 | HILO TRANS-X TRAUMA TRANSPORT | Tecnomed, Inc. | Jan 28, 1980 | SESE |
| K791812 | SPECTRUM EMERGENCY & TRAUMA TABLE SYSTEM | Spectrum X-Ray Corp. | Nov 5, 1979 | SESE |
| K781532 | UROSKOP A AND B | Siemens Corp. | Sep 14, 1978 | SESE |
| K771293 | X-RAY DIAG. TABLE DT-KCS | Toshiba Medical Systems | Aug 3, 1977 | SESE |
| K770334 | TILTING X-RAY TABLE | Litton Medical Systems | Mar 1, 1977 | SESE |
| K760466 | TABLE, X-RAY, RFX CLASSICAL | General Electric Co. | Aug 26, 1976 | 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
