Agfa Model CR30-X
FDA 510(k) K062223 · Agfa Corporation
510(k) numberK062223
Submission
- Device name
- Agfa Model CR30-X
- Applicant
- Agfa Corporation
Greenville, SC, US - Received
- August 2, 2006
- Decision date
- September 1, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K253800 | 0909FCE, 0909FCE-HSMQB · Traditional | Rayence Co., Ltd. | 07/31/2026SE |
| K260820 | Vivix-S 4386W (FXRD-4386WA)MQB · Special | Vieworks Co., Ltd. | 06/18/2026SE |
| K252996 | Universal 1417PIMQB · Abbreviated | Konica Minolta Healthcare Americas, Inc. | 06/12/2026SE |
| K252911 | Lux HD 2530 detector (Lux HD 2530)MQB · Special | Iray Imaging Technology (Haining) Limited | 10/09/2025SE |
| K250211 | Yushan X-Ray Flat Panel DetectorMQB · Traditional | Innocare Optoelectronics Corp. | 07/22/2025SE |
| K250665 | SKR 3000MQB · Traditional | Konica Minolta, Inc. | 06/17/2025SE |
| K243734 | Wireless/ Wired X-Ray Flat Panel DetectorsMQB · Special | Allengers Medical Systems Limited | 04/18/2025SE |
| K242770 | Expd 114; Expd 114G; Expd 114P; Expd 114PGMQB · Special | DRTECH Corporation | 03/20/2025SE |
| K243443 | Expd 4343N1; Expd 4343N; Expd 4343U1; Expd 4343NU; Expd 4343NP; Expd 3643N1; Expd 3643N…MQB · Special | DRTECH Corporation | 03/19/2025SE |
| K243556 | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)MQB · Traditional | Iray Imaging Technology (Haining) Limited | 03/18/2025SE |
More from Iray Imaging Technology (Haining) Limited
| 510(k) | Device | Decision |
|---|---|---|
| K063421 | Dx-SiMQB · Traditional | 11/22/2006SE |
| K062742 | CR 85-XMQB · Special | 10/13/2006SE |
| 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 |
| K042779 | Radiotherapy Solution Based on CRIXK · Traditional | 10/21/2004SE |
| K041701 | Afga CR25.0 Computed Radiography SystemMQB · Special | 07/22/2004SE |
| K040555 | Impax Client EmbraceLLZ · Traditional | 05/26/2004SE |
Questions and answers
When was Agfa Model CR30-X cleared by the FDA?
Agfa Model CR30-X (K062223) received a 510(k) decision of Substantially Equivalent on September 1, 2006, 30 days after the submission was received.
What is the product code of K062223?
The FDA product code is MQB – Solid State X-Ray Imager (Flat Panel/Digital Imager), a Class II (moderate risk) device regulated under 21 CFR 892.1680.