System, Imaging, X-Ray, Electrostatic
Regulation 892.1630
0510(k)s in 12 months (14 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in IXK
| Company | 510(k)s | Recalls |
|---|---|---|
| Fujifilm Medical System U.S.A., Inc. | 4 | 0 |
| Agfa Corp. | 2 | 0 |
| Canon USA, Inc. | 1 | 0 |
| Electron Jsco. | 1 | 0 |
| Orex Computed Radiography, Ltd. | 1 | 0 |
| Orion Corporation Soredex | 1 | 0 |
| Portavision Medical | 1 | 0 |
| Siemens Medical Solutions USA, Inc. | 1 | 0 |
| Xeroradiography | 1 | 0 |
| Xerox Medical Systems | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 29, 2011 | K093640 | DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA Electron Jsco. | IXK |
| Dec 11, 2007 | K072766 | PVMED DDR 2520 DIGITAL IMAGING SYSTEM Portavision Medical | IXK |
| Oct 21, 2004 | K042779 | RADIOTHERAPY SOLUTION BASED ON CR Agfa Corp. | IXK |
| Oct 9, 2003 | K032654 | PORT CASSETTE Orex Computed Radiography, Ltd. | IXK |
| Jan 2, 2002 | K003689 | CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31 Canon USA, Inc. | IXK |
| Feb 16, 2000 | K000159 | AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO Agfa Corp. | IXK |
| Dec 23, 1994 | K942561 | FUJI FCR IMAGE PROCESSING UNIT IP-U515 Fujifilm Medical System U.S.A., Inc. | IXK |
| Feb 10, 1994 | K934949 | DIGORA Orion Corporation Soredex, FI | IXK |
| Jun 8, 1993 | K931002 | FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS Fujifilm Medical System U.S.A., Inc. | IXK |
| Dec 17, 1992 | K924459 | DIGISCAN 2 Siemens Medical Solutions USA, Inc. | IXK |
| Dec 17, 1992 | K923990 | FUJI COMPUTED RADIOGRAPHY HI-C652B DMS CRT IMAGE Fujifilm Medical System U.S.A., Inc. | IXK |
| Oct 16, 1992 | K924012 | FUJI COMPUTED RADIOGRAPHY HI-C653 DMS CRT IMAGE Fujifilm Medical System U.S.A., Inc. | IXK |
| Oct 30, 1985 | K853459 | XERORADIOGRAPHY LIQUID TONER IMAGING SYSTEM Xerox Medical Systems | IXK |
| Nov 24, 1976 | K761022 | XERORADIOGRAPHY 125 SYSTEM - MODIFIED Xeroradiography | IXK |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.