FDA Product Code
FDA Product Code IZO — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1700
510(k) Clearances — 163 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K954666 | MPH50, MPH65, AND MPH80 | GE Medical Systems | 1995-11-24 | Traditional | PDF ↗ |
| K953582 | HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR | Varian Canada, Inc. | 1995-09-26 | Traditional | PDF ↗ |
| K953831 | N 800 HF | Nucletron-Oldelft Corp. | 1995-09-08 | Traditional | PDF ↗ |
| K952822 | SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G | Shimadzu Corp. | 1995-07-12 | Traditional | PDF ↗ |
| K952265 | MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR | Control-X, Inc. | 1995-07-06 | Traditional | PDF ↗ |
| K950883 | POLYDOROS SX 65 AND 80 | Siemens Medical Solutions USA, Inc. | 1995-04-03 | Traditional | PDF ↗ |
| K950694 | COMPACT-X | Electromed Intl., Ltd. | 1995-03-31 | Traditional | PDF ↗ |
| K950291 | DIGITAL 625HF | Fischer Imaging Corp. | 1995-03-23 | Traditional | PDF ↗ |
| K945453 | UD 150L-R II | Shimadzu Medical Systems | 1995-03-21 | Traditional | PDF ↗ |
| K950041 | SII 360 APR | Scott Imaging Intl., Inc. | 1995-03-21 | Traditional | PDF ↗ |
| K950040 | SII 525 APR | Scott Imaging Intl., Inc. | 1995-03-21 | Traditional | PDF ↗ |
| K945452 | UD 150L-F | Shimadzu Medical Systems | 1995-03-21 | Traditional | PDF ↗ |
| K945731 | HFQ HIGH FREQUENCY RADIOGRAPHIC AND FLUROSCOPIC GENERATORS | Bennett X-Ray Corp. | 1995-02-15 | Traditional | PDF ↗ |
| K950037 | N 800 HF | Oldelft Corp. of America | 1995-02-15 | Traditional | PDF ↗ |
| K945668 | KXO-80G | Toshiba America Medical Systems, In.C | 1994-12-27 | Traditional | PDF ↗ |
| K942731 | SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR | Shimadzu Corp. | 1994-10-13 | Traditional | PDF ↗ |
| K944149 | MICRO X-80 HF | Fischer Imaging Corp. | 1994-09-16 | Traditional | PDF ↗ |
| K944148 | MICRO X-30HF | Fischer Imaging Corp. | 1994-09-16 | Traditional | PDF ↗ |
| K944147 | MICRO X-50 HF | Fischer Imaging Corp. | 1994-09-16 | Traditional | PDF ↗ |
| K944150 | MICRO X-65 HF | Fischer Imaging Corp. | 1994-09-16 | Traditional | PDF ↗ |
| K943652 | VASCULAR MP X-RAY GENERATOR | GE Medical Systems | 1994-08-22 | Traditional | PDF ↗ |
| K943504 | RSX-525HF | Fischer Imaging Corp. | 1994-08-17 | Traditional | PDF ↗ |
| K942778 | MODEL VPW2877F8, MAMMO 5 POWER SUPPLY | Varian Assoc., Inc. | 1994-07-29 | Traditional | PDF ↗ |
| K942100 | MODEL TM EP HIGH VOLTAGE GENERATOR | Continental X-Ray Corp. | 1994-06-07 | Traditional | PDF ↗ |
| K934686 | MOLYBDENUM/RHODIUM FILTERS | Continental X-Ray Corp. | 1994-05-26 | Traditional | PDF ↗ |
| K940227 | SCPU X-RAY GENERATOR | General Electric Co. | 1994-04-28 | Traditional | PDF ↗ |
| K934967 | SHIMADZU UD150L-R X-RAY HIGH VOLTAGE GENERATOR | Shimadzu Corp. | 1993-12-13 | Traditional | PDF ↗ |
| K933777 | CONCEPT ONE | Innerscan, Inc. | 1993-12-13 | Traditional | PDF ↗ |
| K935068 | RADIOGRAPHIC GENERATOR HFQ-WHIS | Bennett X-Ray Corp. | 1993-12-13 | Traditional | PDF ↗ |
| K933471 | SHIMADZU X-RAY HIGH VOLTAGE GENERATOR AUD150G | Shimadzu Corp. | 1993-11-24 | Traditional | PDF ↗ |
| K933650 | PHILIPS XRG 90 X-RAY GENERATOR SYSTEM | Philips Medical Systems North America, Inc. | 1993-10-07 | Traditional | PDF ↗ |
| K931930 | POYDOROS LX | Siemens Medical Solutions USA, Inc. | 1993-09-07 | Traditional | PDF ↗ |
| K933240 | POLYDOROS IS | Siemens Medical Solutions USA, Inc. | 1993-09-07 | Traditional | PDF ↗ |
| K931998 | LCR GENERATOR | Philips Medical Systems (Cleveland), Inc. | 1993-07-27 | Traditional | PDF ↗ |
| K931049 | ADVANTX SYSTEM | GE Medical Systems | 1993-05-19 | Traditional | PDF ↗ |
| K930792 | RSX 30HF | Fischer Imaging Corp. | 1993-05-19 | Traditional | PDF ↗ |
| K926365 | MAGMA XHF-30, XHF-40, XHF-50 | Imaging and X-Ray Intl., Inc. | 1993-03-26 | Traditional | PDF ↗ |
| K920349 | PCX 1050HF RADIOGRAPHIC X-RAY GENERATOR | Control-X, Inc. | 1993-02-12 | Traditional | PDF ↗ |
| K920351 | PCX 650HF RADIOGRAPHIC X-RAY | Control-X, Inc. | 1993-02-12 | Traditional | PDF ↗ |
| K925684 | OLYMP-X,X-RAY GENERATOR | Afp Imaging Corp. | 1993-02-02 | Traditional | PDF ↗ |
| K924078 | POLYDOROS C | Siemens Medical Solutions USA, Inc. | 1993-01-26 | Traditional | PDF ↗ |
| K925844 | PHILIPS SUPER CP FAMILY | Philips Medical Systems, Inc. | 1992-12-28 | Traditional | PDF ↗ |
| K925105 | PHILIPS MEDIO CP FAMILY | Philips Medical Systems, Inc. | 1992-12-28 | Traditional | PDF ↗ |
| K923786 | POLYDOROS XS50 AND SX80 | Siemens Medical Solutions USA, Inc. | 1992-12-17 | Traditional | PDF ↗ |
| K921875 | X-RAY CONTROL AND HI-VOLTAGE GENERATOR | Continental X-Ray Corp. | 1992-10-15 | Traditional | PDF ↗ |
| K922814 | TEC1410 ANATOMICAL PROGRAMMING GENERATOR-MODIFICAT | Bay Shore Medical Equipment Corp. | 1992-09-11 | Traditional | PDF ↗ |
| K922165 | ATC725, ATC525, AND AP300 | Gendex Corp. | 1992-07-27 | Traditional | PDF ↗ |
| K921951 | MPG 65-80-100 X-RAY GENERATOR AND CONTROL | General Electric Co. | 1992-07-21 | Traditional | PDF ↗ |
| K921516 | P2900 X-RAY GENERATOR | Precise Optics Photo Medic Equipment, Inc. | 1992-05-28 | Traditional | PDF ↗ |
| K920730 | X-RAY HIGH VOLTAGE GENERATOR ED 125L | Shimadzu Medical Systems | 1992-04-27 | Traditional | PDF ↗ |
| K915339 | GEN-X 800/300 | Swissray Finatech, Inc. | 1992-01-09 | Traditional | PDF ↗ |
| K915227 | GEN-X 800/500 | Swiss Ray Medical Systems | 1992-01-09 | Traditional | PDF ↗ |
| K913222 | OPTIMA | Olympic Controls Corp. | 1991-12-20 | Traditional | PDF ↗ |
| K914266 | MICRO-X 30 HF | Fischer Imaging Corp. | 1991-11-27 | Traditional | PDF ↗ |
| K914236 | MICRO-X 50 HF | Fischer Imaging Corp. | 1991-11-27 | Traditional | PDF ↗ |
| K913577 | MILESTONE MS 325 RADIOGRAPHIC X-RAY GENERATOR | Control-X, Inc. | 1991-11-05 | Traditional | PDF ↗ |
| K913578 | MILESTONE MS 525 RADIOGRAPHIC X-RAY GENERATOR | Control-X, Inc. | 1991-11-01 | Traditional | PDF ↗ |
| K914301 | GEN-X 800/800 | Swissray Finatech, Inc. | 1991-10-30 | Traditional | PDF ↗ |
| K914302 | GEN-X 800/650 | Swissray Finatech, Inc. | 1991-10-30 | Traditional | PDF ↗ |
| K911562 | EDITOR MP 800/HF-850 X-RAY CONTROL AND GENERATOR | Continental X-Ray Corp. | 1991-10-24 | Traditional | PDF ↗ |
| K913234 | VPW2906A1: 480V, 3 PHASE, X-RAY POWER SUPPLY | Varian Canada, Inc. | 1991-09-23 | Traditional | PDF ↗ |
| K913062 | SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B-10 | Shimadzu Medical Systems | 1991-09-16 | Traditional | PDF ↗ |
| K913063 | SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD150B-10 | Shimadzu Medical Systems | 1991-09-16 | Traditional | PDF ↗ |
| K913065 | SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150L | Shimadzu Medical Systems | 1991-09-16 | Traditional | PDF ↗ |
| K913064 | SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD 150L | Shimadzu Medical Systems | 1991-09-16 | Traditional | PDF ↗ |
| K912449 | MICRO-X 15 HF | Fischer Imaging Corp. | 1991-08-28 | Traditional | PDF ↗ |
| K911280 | SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150B | Shimadzu Medical Systems | 1991-06-17 | Traditional | PDF ↗ |
| K910650 | SELECTOR MD (50KW AND 80 KW) | Hofmann-Nagel Medical Systems, Inc. | 1991-06-06 | Traditional | PDF ↗ |
| K911339 | SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150K | Shimadzu Medical Systems | 1991-04-16 | Traditional | PDF ↗ |
| K910020 | CAPINTEC THYROID UPTAKE SYSTEM-VARIOUS MODELS | Capintec Instruments, Inc. | 1991-04-08 | Traditional | PDF ↗ |
| K910820 | VPW 2877E6 X-RAY POWER SUPPLY | Varian Canada, Inc. | 1991-03-07 | Traditional | PDF ↗ |
| K905695 | MICRO-X 80HF | Fischer Imaging Corp. | 1991-03-06 | Traditional | PDF ↗ |
| K905799 | HFQ SERIES CONTROLS AND GENERATORS | Bennett X-Ray Corp. | 1991-02-26 | Traditional | PDF ↗ |
| K904169 | VPW 2903 A-1 -208V, B2-440V,C3-240V X-RAY SUPPLY | Varian Canada, Inc. | 1991-02-19 | Traditional | PDF ↗ |
| K902986 | G.E. DXD 325/350/350II/DXD 525/525II GENERATORS | Electromek Diagnostic Systems, Inc. | 1991-02-13 | Traditional | PDF ↗ |
| K905855 | VPW2877E7 X RAY POWER SUPPLY | Varian Canada, Inc. | 1991-02-13 | Traditional | PDF ↗ |
| K904114 | ANATECH X-RAY GENERATOR | Continental X-Ray Corp. | 1991-01-03 | Traditional | PDF ↗ |
| K902987 | G.E. DXS 350/550/650/650II SINGLE PHASE GENERATORS | Electromek Diagnostic Systems, Inc. | 1990-12-26 | Traditional | PDF ↗ |
| K902988 | G.E. MSI 850/850II/1250 THREE PHASE GENERATORS | Electromek Diagnostic Systems, Inc. | 1990-12-19 | Traditional | PDF ↗ |
| K902985 | G.E. MST 625/625II/MST 1050/1050II THREE PHASE GEN | Electromek Diagnostic Systems, Inc. | 1990-12-19 | Traditional | PDF ↗ |
| K904043 | KXO-80C/80D | Toshiba America Medical Systems, In.C | 1990-11-29 | Traditional | PDF ↗ |
| K904397 | TEC 1410 | Bay Shore Medical Equipment Corp. | 1990-11-13 | Traditional | PDF ↗ |
| K903942 | SHIMADZU X-RAY HIGH VOLTAGE GENERATPR AHD150G | Shimadzu Medical Systems | 1990-10-03 | Traditional | PDF ↗ |
| K902106 | VPW 2877D5, X-RAY POWER SUPPLY | Varian Assoc., Inc. | 1990-08-10 | Traditional | PDF ↗ |
| K902637 | FUTURUS 2001 X-RAY GENERATOR | Acoma Medical Imaging, Inc. | 1990-08-03 | Traditional | PDF ↗ |
| K901951 | MODEL# MPC | Amerisys | 1990-07-11 | Traditional | PDF ↗ |
| K900062 | U.S.I. MODEL 1012, REMOTE FLUOROSCOPIC CONTROL | U.S. Imaging, Inc. | 1990-02-05 | Traditional | PDF ↗ |
| K895969 | RADKOR DXG-650R | Radkor, Inc. | 1989-11-13 | Traditional | PDF ↗ |
| K894479 | 30KW HIGH FREQ. RADIO. GENE. MODELS HFQ-30/HFQ30SE | Bennett X-Ray Corp. | 1989-09-12 | Traditional | PDF ↗ |
| K893674 | RME 325R | Fischer Imaging Corp. | 1989-07-20 | Traditional | PDF ↗ |
| K893681 | MAMM-AIRE CP | Custom Medical Products, Ltd. | 1989-07-20 | Traditional | PDF ↗ |
| K892657 | SENSIMAT | Transworld X-Ray Corp. | 1989-06-23 | Traditional | PDF ↗ |
| K892943 | MULTI PULSE POWER UNIT GENERATOR | GE Medical Systems | 1989-05-22 | Traditional | PDF ↗ |
| K890083 | GX-2000 STATIONARY X-RAY GENERATOR | Gendex Corp. | 1989-03-31 | Traditional | PDF ↗ |
| K890066 | STAR 36 | Transworld X-Ray Corp. | 1989-03-28 | Traditional | PDF ↗ |
| K884678 | ESP 3-PHASE X-RAY GENERATORS | Elscint, Inc. | 1989-01-17 | Traditional | PDF ↗ |
| K883976 | CFX 625 | Fischer Imaging Corp. | 1988-12-13 | Traditional | PDF ↗ |
| K884134 | MICRO-X 100CP | Fischer Imaging Corp. | 1988-10-21 | Traditional | PDF ↗ |
| K883431 | RAYMAX 2100 MODELS 2130 & 2136 | Raymax Medical Corp. | 1988-09-12 | Traditional | PDF ↗ |
| K883154 | SELDIX 325 TWO PULSE GENERATOR/CONTROL | Bay X-Ray, Inc. | 1988-09-06 | Traditional | PDF ↗ |
Product code IZO · Class I · Radiology. Data: openFDA.