Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
IXR — Predicate Candidate Screening
77 FDA 510(k) clearances under this product code; the 50 most recent screened below.
51 daysmedian FDA review time
161 days90th percentile
77clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K000412 | VISION R/F TILTING TABLE | Villa Sistemi Medicali S.P.A. | 2000-04-24 | 76 | 0 |
| K973039 | LEGACY/LEGACY-D TABLE | GE Medical Systems | 1997-10-16 | 63 | 4 |
| K971128 | CAP-35B III/CINE 275 | Jamieson Film Co. | 1997-04-28 | 32 | 0 |
| K970640 | PHILIPS EASY DIAGNOST | Philips Medical Systems North America, Inc. | 1997-03-21 | 29 | 5 |
| K965105 | ELECTROPHYSIOLOGY TILT TABLE MODEL #9660 | U.S. Imaging Tables, Inc. | 1997-01-30 | 41 | 0 |
| K965096 | FLUOROVIEW SERIES FLUOROSCOPIC TABLES | U.S. Imaging Tables, Inc. | 1997-01-27 | 38 | 0 |
| K963851 | TILTING RADIOGRAPHIC TABLE (REMOTE) | Acoma Medical Imaging, Inc. | 1997-01-23 | 120 | 0 |
| K961022 | TANGENT VI TABLE | Fischer Imaging Corp. | 1996-05-03 | 50 | 0 |
| K954356 | COMPAX 90/15E | General Electric Co. | 1995-10-07 | 19 | 0 |
| K953557 | SURGICAL C-ARM TABLE, 9610 | U.S. Imaging Tables, Inc. | 1995-09-26 | 71 | 0 |
| K953556 | VACS TABLE, 9650 | U.S. Imaging Tables, Inc. | 1995-09-26 | 71 | 0 |
| K951176 | KOORDINAT M | Siemens Medical Solutions USA, Inc. | 1995-04-20 | 36 | 0 |
| K950981 | ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650 | Biodex Medical Systems, Inc. | 1995-04-03 | 31 | 0 |
| K950402 | CORSINI 9090 | C.A.T. DI Corsini G. & C. Spa | 1995-03-31 | 58 | 0 |
| K945842 | MOBILIX MOBILE X-RAY TABLE | GE Medical Systems | 1995-01-18 | 49 | 0 |
| K943581 | HYDRADJUST IV UROLOGICAL TABLE | Mallinckrodt Group, Inc. | 1995-01-04 | 166 | 2 |
| K944987 | URO - ELITE TABLE ACCESSORIES | Philips Medical Systems (Cleveland), Inc. | 1994-11-30 | 49 | 0 |
| K935444 | OCTOSTOP(R) CHAIR (NEW MODEL | Octostop, Inc. | 1994-09-02 | 294 | 0 |
| K940721 | CLINIX VP 4 TABLE | Philips Medical Systems (Cleveland), Inc. | 1994-05-03 | 74 | 0 |
| K934574 | MODEL MPFT-01, GENESIS | International Medical Designs, Inc. | 1994-03-04 | 169 | 0 |
| K931563 | SPECTRUM MARK I SPECIAL PROCEDURES TABLE | Spectrum X-Ray Corp. | 1993-08-23 | 146 | 0 |
| K924326 | ARTHRODYN 45 DEGREE X-RAY TABLE | Arthrodyn, Inc. | 1993-04-08 | 224 | 0 |
| K922591 | UROLOGICAL C-ARM TABLE, MODEL #056-450 | Biodan Medical Systems, Ltd. | 1992-11-27 | 178 | 0 |
| K925175 | SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-200 30/90 | Shimadzu Medical Systems | 1992-11-27 | 45 | 0 |
| K922364 | DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST | Toshiba America Medical Systems, In.C | 1992-09-04 | 108 | 1 |
| K920726 | UROLOGICAL X-RAY TABLE HS-10A | Shimadzu Medical Systems | 1992-05-29 | 101 | 0 |
| K920728 | X-RAY DIAGNOSTIC TABLE YSF-100 | Shimadzu Medical Systems | 1992-05-28 | 100 | 0 |
| K920742 | HYDRAJUST IV UROLOGICAL TABLE | Mallinckrodt Group, Inc. | 1992-04-27 | 68 | 1 |
| K920722 | X-RAY DIAGNOSTIC TABLE YSF-200-30-90 | Shimadzu Medical Systems | 1992-04-13 | 55 | 0 |
| K914417 | MEDIQUIP I.A. FIELD CONV KIT/AMSCO 2080 SER TABLE | Med-Vac, Inc. | 1992-02-27 | 147 | 0 |
| K912996 | MODIF TOP DRIVE BOARD CXT-90 90/90 DIAG TILT TABLE | Continental X-Ray Corp. | 1992-02-03 | 210 | 0 |
| K915853 | TANGENT V | Fischer Imaging Corp. | 1992-01-24 | 28 | 0 |
| K914165 | X-RAY TABLE | Siemens Medical Solutions USA, Inc. | 1991-11-05 | 49 | 0 |
| K912741 | ELITE R 90/15 | Fischer Imaging Corp. | 1991-10-04 | 105 | 0 |
| K913147 | SHIMADZU MULTI-DIRECTIONAL DIAGNOSTIC TABLE VS-100 | Shimadzu Medical Systems | 1991-09-19 | 65 | 0 |
| K910838 | TREATMENT TABLE | Tri W-G, Inc. | 1991-08-07 | 161 | 0 |
| K912586 | TANGENT IV | Fischer Imaging Corp. | 1991-08-02 | 51 | 0 |
| K911098 | PHILIPS URO DIAGNOST MRF | Philips Medical Systems, Inc. | 1991-07-03 | 113 | 1 |
| K911267 | RADIOGRAPHIC/FLUOROSCOPIC TABLE MODEL 9004 | Tri W-G, Inc. | 1991-04-03 | 23 | 0 |
| K905265 | 620 FLUOROSCOPIC TABLE, TILT OR POWER MEDICAL TAB | Tri W-G, Inc. | 1991-01-23 | 61 | 0 |
| K905501 | ELITE 5000 | Fischer Imaging Corp. | 1991-01-18 | 42 | 0 |
| K905153 | REMOTE CONTROLLED X-RAY DIAGNOSTIC RS-110 | Shimadzu Medical Systems | 1990-12-11 | 26 | 0 |
| K905152 | REMOTE CONTROLLED X-RAY DIAG. RSZ-200 | Shimadzu Medical Systems | 1990-12-11 | 26 | 0 |
| K901654 | MTT 90 UNIVERSAL REMOTE-CONTROLLED X-RAY TABLE | Imt America, Inc. | 1990-11-23 | 227 | 0 |
| K902989 | G.E. MONITROL 90 AND G.E. MONITROL 15 | Electromek Diagnostic Systems, Inc. | 1990-10-29 | 125 | 0 |
| K903422 | MT-15 RADIOGRAPHIC/FLUOROSCOPIC TILT TABLE | Imt America, Inc. | 1990-09-04 | 35 | 0 |
| K903395 | UROMAT 2000 | Pausch Corp. | 1990-08-30 | 34 | 0 |
| K896583 | F.A.S.T. TABLE | Oec-Diasonics, Inc. | 1990-03-01 | 100 | 0 |
| K896119 | RMS 90/15 RADIOGRAPHIC/FLUOROSCOPIC TILTING TABLE | Rms Div. | 1989-11-27 | 34 | 0 |
| K896324 | ELITE 1500 RADIOGRAPHIC TILTING TABLE | Rms Div. | 1989-11-21 | 20 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda