Medicatech USA
Anaheim, CA, US
MEDICATECH USA appears in FDA device records in Anaheim, CA. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Medicatech USA between 2008 and 2025. The busiest year on record is 2011, with 3. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 2 |
| 2011 | 3 |
| 2013 | 1 |
| 2015 | 1 |
| 2019 | 1 |
| 2023 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242731 | MasteRad MiniX Mobile Digital Imaging System (Mini-X) | OWB | Substantially Equivalent | |
| K230918 | MasterX 800 Series | MQB | Substantially Equivalent | |
| K190601 | MasteRad MX30 | KPR | Substantially Equivalent | |
| K143257 | KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System | KPR | Substantially Equivalent | |
| K130377 | KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM | MQB | Substantially Equivalent | |
| K112132 | KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM | MQB | Substantially Equivalent | |
| K102285 | KRYSTALRAD (ATAL8) | KPR | Substantially Equivalent | |
| K102284 | KRYSTALRAD 560 (FLAATZ 560) | KPR | Substantially Equivalent | |
| K082798 | DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 3000 | KPR | Substantially Equivalent | |
| K080582 | MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA | KPR | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004989804 | 3004989804 | MEDICATECH USA | 1245 N Patt St, Anaheim, CA 92801 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain
