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 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K883081 | RADKOR, XG-515 | Radkor, Inc. | 1988-09-02 | Traditional | PDF ↗ |
| K881696 | RADKOR XG-325 | Radkor, Inc. | 1988-09-02 | Traditional | PDF ↗ |
| K880525 | 3 PHASE HIGH FREQ. DIAG. X-RAY GEN. MICRO-X 60HF | Fischer Imaging Corp. | 1988-08-15 | Traditional | PDF ↗ |
| K881886 | MODIFIED X-RAY CONTROLS, MODEL ED125L AND ED150L | U.S. Imaging, Inc. | 1988-08-04 | Traditional | PDF ↗ |
| K881387 | X-RAY GENERATING SYSTEM, TF 800 | Absolute X-Ray Corp. | 1988-07-08 | Traditional | PDF ↗ |
| K881386 | X-RAY GENERATING SYSTEM TF 1000 | General Medical Merate S.P.A | 1988-07-08 | Traditional | PDF ↗ |
| K881795 | SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150K | Shimadzu Precision Instruments, Inc. | 1988-07-01 | Traditional | PDF ↗ |
| K880524 | THREE PHASE DIAGNOSTIC X-RAY GENERATOR MICRO-X 100 | Fischer Imaging Corp. | 1988-05-04 | Traditional | PDF ↗ |
| K880519 | SINGLE PHASE DIAG. X-RAY GENERATOR MICRO-X 650 | Fischer Imaging Corp. | 1988-05-04 | Traditional | PDF ↗ |
| K880522 | THREE PHASE, DIAGNOSTIC X-RAY GENERATOR MICRO-X 80 | Fischer Imaging Corp. | 1988-05-04 | Traditional | PDF ↗ |
| K880523 | THREE PHASE, DIAGNOSTIC GENERATOR MICRO-X 75 | Fischer Imaging Corp. | 1988-05-04 | Traditional | PDF ↗ |
| K880521 | SINGLE PHASE DIAGNOSTIC X-RAY GENERATOR FX-650 | Fischer Imaging Corp. | 1988-05-04 | Traditional | PDF ↗ |
| K880532 | SINGLE PHASE DIAGNOSTIC X-RAY GENERATOR FX 350 | Fischer Imaging Corp. | 1988-03-28 | Traditional | PDF ↗ |
| K874946 | SHIMADZU X-RAY HIGH VOLTAGE GENERATOR HD150G-60 | Shimadzu Precision Instruments, Inc. | 1988-03-03 | Traditional | PDF ↗ |
| K880050 | EDEC 60R | Electromed Intl., Ltd. | 1988-02-29 | Traditional | PDF ↗ |
| K875341 | EDEC 60 R/F | Electromed Intl., Ltd. | 1988-02-01 | Traditional | PDF ↗ |
| K875342 | EDEC 90C | Electromed Intl., Ltd. | 1988-01-29 | Traditional | PDF ↗ |
| K873544 | MPG-50 X-RAY GENERATOR | Thomson-Cgr Medical Corp. | 1987-10-26 | Traditional | PDF ↗ |
| K872445 | POWER-AID INDEPENDENT X-RAY POWER SOURCE | Advanced Instrument Development, Inc. | 1987-08-12 | Traditional | PDF ↗ |
| K864624 | PROBE, UPTAKE, NUCLEAR | Carolina Medical Electronics | 1987-08-10 | Traditional | PDF ↗ |
| K872357 | TRANSWORLD 360V, MODEL A1-4040 | Transworld X-Ray Corp. | 1987-07-15 | Traditional | PDF ↗ |
| K871145 | EDEC 50C CONSTANT POTENTIAL X-RAY GENERATOR | Electromed Intl., Ltd. | 1987-03-31 | Traditional | PDF ↗ |
| K870851 | EDEC 80 CONSTANT POTENTIAL X-RAY GENERATOR | Electromed Intl., Ltd. | 1987-03-20 | Traditional | PDF ↗ |
| K864339 | PORTA RAY MODEL 325 | Porta Ray, Inc. | 1986-12-15 | Traditional | PDF ↗ |
| K862800 | SMX GENERATOR | General Electric Co. | 1986-08-14 | Traditional | PDF ↗ |
| K862682 | MVP GENERATOR, CATALOG NO. H8018 | General Electric Co. | 1986-07-29 | Traditional | PDF ↗ |
| K854499 | GENDEX PRINCE 30 MEDICAL X-RAY GENERATOR | Gendex Corp. | 1986-04-22 | Traditional | PDF ↗ |
| K860736 | FISCHER IMAGING FX325R X-RAY GENERATOR | Fischer Imaging Corp. | 1986-04-17 | Traditional | PDF ↗ |
| K860203 | TXR 325 X-RAY CONTROL WITH HIGH VOLTAGE GENERATOR | Tingle X-Ray Products, Inc. | 1986-01-30 | Traditional | PDF ↗ |
| K852908 | EDEC 2000 | Electromed Intl., Ltd. | 1985-11-29 | Traditional | PDF ↗ |
| K851011 | HOFMANN G-S60 SINGLE PHASE X-RAY GENERATOR | Hofmann X-Ray of America, Inc. | 1985-04-10 | Traditional | PDF ↗ |
| K850823 | SRX 200 DIAGNOSTIC X-RAY, HIGH VOLTAGE GENERATOR | Philips Medical Systems (Cleveland), Inc. | 1985-04-10 | Traditional | PDF ↗ |
| K850117 | XMA 325 (X-RAY GENERATOR) | Summit Industries, Inc. | 1985-04-09 | Traditional | PDF ↗ |
| K843443 | EDEC-100 | Electromed Intl., Ltd. | 1985-03-01 | Traditional | PDF ↗ |
| K842348 | SPX GENERATOR | General Electric Co. | 1984-08-17 | Traditional | PDF ↗ |
| K833846 | PROCESS 100 ST | Cgr Medical Corp. | 1983-12-16 | Traditional | PDF ↗ |
| K820593 | ESP SERIES (X-RAY GENERATORS | Xonics Medical Systems, Inc. | 1982-03-19 | Traditional | PDF ↗ |
| K820307 | TECNOMED GENERATOR, RADIOGRAPH., 3 PHASE | Tecnomed, Inc. | 1982-03-05 | Traditional | PDF ↗ |
| K820112 | SIEMENS POLYDOROS 800 | Siemens Corp. | 1982-02-24 | Traditional | PDF ↗ |
| K813051 | COMPTAR III | Cgr Medical Corp. | 1981-11-24 | Traditional | PDF ↗ |
| K812616 | POLYPHOS 500 | Siemens Corp. | 1981-10-13 | Traditional | PDF ↗ |
| K811198 | ECCO GENERATOR | Philips Medical Systems (Cleveland), Inc. | 1981-06-29 | Traditional | PDF ↗ |
| K802941 | CINESCOPE III RADIOGRAPHIC GENERATOR | Controtec, Inc. | 1981-01-09 | Traditional | PDF ↗ |
| K802996 | VECTOR-100 X-RAY GENERATOR | Philips Medical Systems (Cleveland), Inc. | 1981-01-09 | Traditional | PDF ↗ |
| K802548 | GENERATOR, HIGH VOLT, X-RAY, DIAG. MPX80 | General Electric Co. | 1980-12-02 | Traditional | PDF ↗ |
| K802549 | GENERATOR, HIGH VOLT, X-RAY, MPX 100 | General Electric Co. | 1980-12-02 | Traditional | PDF ↗ |
| K802551 | GENERATOR, HIGH VOLT, X-RAY, MPX100/125 | General Electric Co. | 1980-12-02 | Traditional | PDF ↗ |
| K802550 | GENERATOR, HIGH VOLT, X-RAY, MPX 125 | General Electric Co. | 1980-12-02 | Traditional | PDF ↗ |
| K801808 | BR 2002 X-RAY GENERATOR SYSTEM | Valmet Indus. Mach. & Prod., Inc. | 1980-09-26 | Traditional | PDF ↗ |
| K801408 | CINESCOPE III | Philips Medical Systems (Cleveland), Inc. | 1980-07-28 | Traditional | PDF ↗ |
| K792392 | POLYPHOS | Siemens Corp. | 1979-12-20 | Traditional | PDF ↗ |
| K792393 | GIGANTOS 1012 MP | Siemens Corp. | 1979-12-20 | Traditional | PDF ↗ |
| K791933 | CONVERSION CONTRACTOR TIMER KIT | Advanced Instrument Development, Inc. | 1979-11-13 | Traditional | PDF ↗ |
| K791214 | TRIDOROS 712 | Siemens Corp. | 1979-07-30 | Traditional | PDF ↗ |
| K780742 | INTRAORAL DENTAL X-RAY GENERATOR | Siemens Corp. | 1978-07-27 | Traditional | PDF ↗ |
| K771294 | X-RAY GENERATOR MODEL KXO-15 | Toshiba Medical Systems | 1977-08-03 | Traditional | PDF ↗ |
| K771295 | X-RAY GENERATOR MODEL KX0-825 | Toshiba Medical Systems | 1977-08-03 | Traditional | PDF ↗ |
| K770338 | X-RAY CONTROL & X-RAY HV GENERATOR | Litton Medical Systems | 1977-03-01 | Traditional | PDF ↗ |
| K770006 | MPX 80 | General Electric Co. | 1977-01-18 | Traditional | PDF ↗ |
| K770008 | MPX 125 | General Electric Co. | 1977-01-18 | Traditional | PDF ↗ |
| K770007 | MPX 100 | General Electric Co. | 1977-01-18 | Traditional | PDF ↗ |
| K760569 | THREE PHASE X-RAY CONTROLS & HV GENERATORS | Litton Medical Systems | 1976-09-15 | Traditional | PDF ↗ |
| K760568 | SINGLE PHASE X-RAY CONTROLS & HV GENERATORS | Litton Medical Systems | 1976-09-15 | Traditional | PDF ↗ |
Product code IZO · Class I · Radiology. Data: openFDA.