Radiotherapy Solution Based on CR
FDA 510(k) K042779 · Agfa Corp.
510(k) numberK042779
Submission
- Device name
- Radiotherapy Solution Based on CR
- Applicant
- Agfa Corp.
Greenville, SC, US - Received
- October 6, 2004
- Decision date
- October 21, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Other 510(k)s with product code IXK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K093640 | Digital X-Ray Detectors Family KRC and DiraIXK · Traditional | Electron Jsco. | 04/29/2011SE |
| K072766 | Pvmed DDR 2520 Digital Imaging SystemIXK · Traditional | Portavision Medical | 12/11/2007SE |
| K032654 | Port CassetteIXK · Traditional | Orex Computed Radiography, Ltd. | 10/09/2003SE |
| K003689 | Canon X-Ray Digital Camera, Model CXDI-31IXK · Traditional | Canon USA, Inc. | 01/02/2002SE |
| K000159 | Agfa Diagnostic Center Adc, Adc Compact, and Adc SoloIXK · Special | Agfa Corp. | 02/16/2000SE |
| K942561 | Fuji FCR Image Processing Unit IP-U515IXK · Traditional | Fujifilm Medical System U.S.A., Inc. | 12/23/1994SE |
| K934949 | DigoraIXK · Traditional | Orion Corporation Soredex | 02/10/1994SE |
| K931002 | Fuji Computed Radiograp HI-C654 DMS CRT Image ConsIXK · Traditional | Fujifilm Medical System U.S.A., Inc. | 06/08/1993SE |
| K924459 | Digiscan 2IXK · Traditional | Siemens Medical Solutions USA, Inc. | 12/17/1992SE |
| K923990 | Fuji Computed Radiography HI-C652B DMS CRT ImageIXK · Traditional | Fujifilm Medical System U.S.A., Inc. | 12/17/1992SE |
More from Fujifilm Medical System U.S.A., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K063421 | Dx-SiMQB · Traditional | 11/22/2006SE |
| K062742 | CR 85-XMQB · Special | 10/13/2006SE |
| K062223 | Agfa Model CR30-XMQB · Special | 09/01/2006SE |
| K053634 | Computed Radiography System with NX 1.0 WorkstationMQB · Special | 01/17/2006SE |
| K053458 | WEB1000LLZ · Traditional | 12/22/2005SE |
| K052251 | Drystar Model 5500LMC · Traditional | 08/31/2005SE |
| K050810 | Agfa CR50.0MQB · Special | 04/21/2005SE |
| K050751 | Impax Orthopaedic Workstation, Model Impax Es 5.XLLZ · Special | 04/21/2005SE |
| K041701 | Afga CR25.0 Computed Radiography SystemMQB · Special | 07/22/2004SE |
| K040555 | Impax Client EmbraceLLZ · Traditional | 05/26/2004SE |
Questions and answers
When was Radiotherapy Solution Based on CR cleared by the FDA?
Radiotherapy Solution Based on CR (K042779) received a 510(k) decision of Substantially Equivalent on October 21, 2004, 15 days after the submission was received.
What is the product code of K042779?
The FDA product code is IXK – System, Imaging, X-Ray, Electrostatic, a Class II (moderate risk) device regulated under 21 CFR 892.1630.