Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Alphatek with 5 510(k) clearances. The most recent is a 510(k) clearance dated Jan 23, 2003: AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036.
| Date | Record | Source |
|---|---|---|
| Jan 23, 2003 | AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036K023613 · IXW | 510(k) clearances |
| Aug 23, 1993 | MAMMO-300 AUTOMATIC X-RAY FILM PROCESSORK931882 · IXW | 510(k) clearances |
| Aug 23, 1993 | AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033K931883 · IXW | 510(k) clearances |
| Jan 15, 1993 | AX-700LE AUTOMATIC X-RAY FILM PROCESSORK925569 · IXW | 510(k) clearances |
| Nov 27, 1992 | AX-300SE AUTOMATIC X-RAY FILM PROCESSOR, 6586.027K924430 · IXW | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
