Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of OSI SystemsLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list American Science & Engineering with 3 510(k) clearances and 1 device recall. The most recent is a device recall dated May 22, 2015: American Science & Engineering Inc,Gemini Cabinet X-ray system..
| May 22, 2015 | American Science & Engineering Inc,Gemini Cabinet X-ray system.Class II · During factory testing, we discovered that Gemini systems could, in rare circumstances, experience a fault that leads to | Device recalls |
| Dec 8, 1983 | DIGITAL RADIOGRAPHY SYS DUAL GANTRIESK833237 · JAA | 510(k) clearances |
| Dec 16, 1976 | X-RAY SCANNER, WHOLE BODY, AS&EK761004 · IZF | 510(k) clearances |
| Oct 5, 1976 | X-RAY SCANNER, COMPUTERIZED TOMOGRAPHICK760201 · JAK | 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
