Data / Medical devices / United States / Medicatech Usa
Medicatech Usa: FDA-registered device maker in Anaheim, CA, United States, 5 510(k) clearances
Medicatech Usa is registered with the FDA (registration 3004989804) in Anaheim, CA, United States. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 1, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004989804
- Address
- 1245 N Patt St, Anaheim, CA, United States, 92801
- Owner or operator
- Medicatech USA (9073041)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- January 7, 2009
- Registered through
- 2026
- Brand names listed
- KrystaRad 1100, KrystalRad1100, MAK1100, MasteRad MX30, MasteRad® MX PACS, MasteRad® MX40, MasterX 800 Series, MasterX801C and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Digital Image Storage, Radiological | LMB | 1 | Manufacturer | accessdata.fda.gov |
| Generator, High-Voltage, X-Ray, Diagnostic | IZO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| System, X-Ray, Stationary | KPR | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 1, 2023 | K230918 | MasterX 800 Series | MQB | Substantially Equivalent | Medicatech USA | accessdata.fda.gov |
| April 25, 2019 | K190601 | MasteRad MX30 | KPR | Substantially Equivalent | Medicatech USA | accessdata.fda.gov |
| February 6, 2015 | K143257 | KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System | KPR | Substantially Equivalent | Medicatech USA | accessdata.fda.gov |
| October 28, 2008 | K082798 | DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 3000 | KPR | Substantially Equivalent | Medicatech USA | accessdata.fda.gov |
| May 15, 2008 | K080582 | MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA | KPR | Substantially Equivalent | Medicatech USA | accessdata.fda.gov |
Compare with other makers
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
- All makers of System, X-Ray, Stationary
- All makers of Device, Digital Image Storage, Radiological
- All makers of Generator, High-Voltage, X-Ray, Diagnostic
Updated September 1, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.