Krystalrad 560 (Flaatz 560)
FDA 510(k) K102284 · Medicatech USA
510(k) numberK102284
Submission
- Device name
- Krystalrad 560 (Flaatz 560)
- Applicant
- Medicatech USA
Naples, FL, US - Received
- August 12, 2010
- Decision date
- January 3, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K253446 | AeroDR TX c02KPR · Traditional | Dk Medical Systems Co., Ltd. | 04/10/2026SE |
| K250954 | DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…KPR · Traditional | Carestream Health | 01/20/2026SE |
| K252000 | uDR Arria & uDR ArisKPR · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 11/26/2025SE |
| K251167 | uDR Aurora CXKPR · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 09/19/2025SE |
| K250788 | Definium Tempo SelectKPR · Traditional | Ge Hualun Medical Systems Co. , Ltd. | 08/28/2025SE |
| K250790 | Innovision-DxiiKPR · Traditional | Dk Medical Systems Co., Ltd. | 08/01/2025SE |
More from Dk Medical Systems Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K242731 | MasteRad MiniX Mobile Digital Imaging System (Mini-X)OWB · Traditional | 05/16/2025SE |
| K230918 | MasterX 800 SeriesMQB · Traditional | 09/01/2023SE |
| K190601 | MasteRad MX30KPR · Traditional | 04/25/2019SE |
| K143257 | KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic SystemKPR · Traditional | 02/06/2015SE |
| K130377 | Krystalrad New Seriesdigital Radiographic Portable Retrofit SystemMQB · Special | 05/17/2013SE |
| K112132 | Krystalrad 660 Digital Radiographic Portable Retrofit SystemMQB · Traditional | 11/18/2011SE |
| K102285 | Krystalrad (ATAL8)KPR · Traditional | 01/03/2011SE |
| K082798 | Digital Diagnostic X-Ray System, Models Mak 1500, Mak 2000 and Mak 3000KPR · Special | 10/28/2008SE |
| K080582 | Medicatech, Model DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FaKPR · Traditional | 05/15/2008SE |
Questions and answers
When was Krystalrad 560 (Flaatz 560) cleared by the FDA?
Krystalrad 560 (Flaatz 560) (K102284) received a 510(k) decision of Substantially Equivalent on January 3, 2011, 144 days after the submission was received.
What is the product code of K102284?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.