Krystalrad New Seriesdigital Radiographic Portable Retrofit System
FDA 510(k) K130377 · Medicatech USA
510(k) numberK130377
Submission
- Device name
- Krystalrad New Seriesdigital Radiographic Portable Retrofit System
- Applicant
- Medicatech USA
Naples, FL, US - Received
- February 14, 2013
- Decision date
- May 17, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
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| 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 |
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| 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 |
| K112132 | Krystalrad 660 Digital Radiographic Portable Retrofit SystemMQB · Traditional | 11/18/2011SE |
| K102285 | Krystalrad (ATAL8)KPR · Traditional | 01/03/2011SE |
| K102284 | Krystalrad 560 (Flaatz 560)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 New Seriesdigital Radiographic Portable Retrofit System cleared by the FDA?
Krystalrad New Seriesdigital Radiographic Portable Retrofit System (K130377) received a 510(k) decision of Substantially Equivalent on May 17, 2013, 92 days after the submission was received.
What is the product code of K130377?
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.