510(k) K032654
- Device
- PORT CASSETTE
- Applicant
- OREX COMPUTED RADIOGRAPHY LTD
- 510(k) number
- K032654
- Product code
- IXK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-10-09
- Date received
- 2003-08-28
- Regulation
- 892.1630
- Classification name
- System, Imaging, X-ray, Electrostatic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARY MCNAMARA-CULLINANE
- Address
- 49 Plain St. North Attleboro MA US 02760 02760
Source Documents#
Other 510(k) Records For Product Code IXK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K093640 | DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA | Electron Jsco. | 2011-04-29 |
| K072766 | PVMED DDR 2520 DIGITAL IMAGING SYSTEM | Portavision Medical | 2007-12-11 |
| K042779 | RADIOTHERAPY SOLUTION BASED ON CR | Agfa Corp. | 2004-10-21 |
| K003689 | CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31 | Canon USA, Inc. | 2002-01-02 |
| K000159 | AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO | Agfa Corp. | 2000-02-16 |
| K942561 | FUJI FCR IMAGE PROCESSING UNIT IP-U515 | Fujifilm Medical System U.S.A., Inc. | 1994-12-23 |
| K934949 | DIGORA | Orion Corporation Soredex | 1994-02-10 |
| K931002 | FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS | Fujifilm Medical System U.S.A., Inc. | 1993-06-08 |
| K923990 | FUJI COMPUTED RADIOGRAPHY HI-C652B DMS CRT IMAGE | Fujifilm Medical System U.S.A., Inc. | 1992-12-17 |
| K924459 | DIGISCAN 2 | Siemens Medical Solutions USA, Inc. | 1992-12-17 |
| K924012 | FUJI COMPUTED RADIOGRAPHY HI-C653 DMS CRT IMAGE | Fujifilm Medical System U.S.A., Inc. | 1992-10-16 |
| K853459 | XERORADIOGRAPHY LIQUID TONER IMAGING SYSTEM | Xerox Medical Systems | 1985-10-30 |
| K761022 | XERORADIOGRAPHY 125 SYSTEM - MODIFIED | Xeroradiography | 1976-11-24 |
Legacy Summary#
summary
FDA Review#
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