# Medicatech USA

- Location (FDA's records): Irvine, CA
- FDA decisions: 10 (2008–2025): 10 510(k) clearances
- Names in FDA's records: Medicatech USA (9); Medicatech USA, Inc. (1)
- Product codes: KPR (6), MQB (3), OWB (1)
- 510(k) review time since 2016: median 151 days, against 33 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 16 (5 its own); citations of its devices by later devices: 8 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- DRTECH Corporation: 3 (https://510kreport.com/company/drtech)
- Sedecal., Sa.: 3 (https://510kreport.com/company/sedecal)
- Imagexray, LLC: 1 (https://510kreport.com/company/imagexray)
- Imaging Engineering, LLC: 1 (https://510kreport.com/company/imaging-engineering)
- Portavision Medical, LLC: 1 (https://510kreport.com/company/portavision-medical)
- Modern Module, Inc.: 1 (https://510kreport.com/company/modern-module)
- Philips Medical Systems North America, Inc.: 1 (https://510kreport.com/company/philips-medical-systems-north-america)

## Firms that cite its devices most
- DRTECH Corporation: 1 (https://510kreport.com/company/drtech)
- Sedecal., Sa.: 1 (https://510kreport.com/company/sedecal)
- Beijing Polycon Medical Engineering Company: 1 (https://510kreport.com/company/beijing-polycon-medical-engineering)

## Its most-cited devices
- K112132: Krystalrad 660 Digital Radiographic Portable Retrofit System (2011), cited by 2
- K080582: Medicatech, Model DDR Mak-800, DDT Mak-1000 FS, DDR Mak-1100 FA (2008), cited by 2
- K143257: KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System (2015), cited by 2
- K102284: Krystalrad 560 (Flaatz 560) (2011), cited by 1
- K130377: Krystalrad New Seriesdigital Radiographic Portable Retrofit System (2013), cited by 1

## Recent decisions
- K242731: MasteRad MiniX Mobile Digital Imaging System (Mini-X) (May 16, 2025)
- K230918: MasterX 800 Series (Sep 1, 2023)
- K190601: MasteRad MX30 (Apr 25, 2019)
- K143257: KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System (Feb 6, 2015)
- K130377: Krystalrad New Seriesdigital Radiographic Portable Retrofit System (May 17, 2013)
- K112132: Krystalrad 660 Digital Radiographic Portable Retrofit System (Nov 18, 2011)
- K102284: Krystalrad 560 (Flaatz 560) (Jan 3, 2011)
- K102285: Krystalrad (ATAL8) (Jan 3, 2011)

Source page: https://510kreport.com/company/medicatech-usa