FDA Product Code
FDA Product Code IXK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1630
510(k) Clearances — 14 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K093640 | DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA | Electron Jsco. | 2011-04-29 | Traditional | PDF ↗ |
| K072766 | PVMED DDR 2520 DIGITAL IMAGING SYSTEM | Portavision Medical | 2007-12-11 | Traditional | PDF ↗ |
| K042779 | RADIOTHERAPY SOLUTION BASED ON CR | Agfa Corp. | 2004-10-21 | Traditional | PDF ↗ |
| K032654 | PORT CASSETTE | Orex Computed Radiography, Ltd. | 2003-10-09 | Traditional | PDF ↗ |
| K003689 | CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31 | Canon USA, Inc. | 2002-01-02 | Traditional | PDF ↗ |
| K000159 | AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO | Agfa Corp. | 2000-02-16 | Special | PDF ↗ |
| K942561 | FUJI FCR IMAGE PROCESSING UNIT IP-U515 | Fujifilm Medical System U.S.A., Inc. | 1994-12-23 | Traditional | PDF ↗ |
| K934949 | DIGORA | Orion Corporation Soredex | 1994-02-10 | Traditional | PDF ↗ |
| K931002 | FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS | Fujifilm Medical System U.S.A., Inc. | 1993-06-08 | Traditional | PDF ↗ |
| K924459 | DIGISCAN 2 | Siemens Medical Solutions USA, Inc. | 1992-12-17 | Traditional | PDF ↗ |
| K923990 | FUJI COMPUTED RADIOGRAPHY HI-C652B DMS CRT IMAGE | Fujifilm Medical System U.S.A., Inc. | 1992-12-17 | Traditional | PDF ↗ |
| K924012 | FUJI COMPUTED RADIOGRAPHY HI-C653 DMS CRT IMAGE | Fujifilm Medical System U.S.A., Inc. | 1992-10-16 | Traditional | PDF ↗ |
| K853459 | XERORADIOGRAPHY LIQUID TONER IMAGING SYSTEM | Xerox Medical Systems | 1985-10-30 | Traditional | PDF ↗ |
| K761022 | XERORADIOGRAPHY 125 SYSTEM - MODIFIED | Xeroradiography | 1976-11-24 | Traditional | PDF ↗ |
Product code IXK · Class II · Radiology. Data: openFDA.