Medical device makerLabelled 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 14, 2026, FDA's public records list Bio-Scan with 7 510(k) clearances. The most recent is a 510(k) clearance dated May 21, 2002: SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW.
| May 21, 2002 | SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEWK013897 · MQB | 510(k) clearances |
| May 11, 2001 | BIOFINDK003480 · GZO | 510(k) clearances |
| Dec 3, 1993 | EEG ANALYZERK925735 · GWS | 510(k) clearances |
| Mar 31, 1987 | BIO-LOG 8+1 AMBULATORY PHYSIOLOGIC RECORDERK864928 · GWQ | 510(k) clearances |
| Jun 7, 1984 | Q.P. PREAMPLIFIER SYSK841683 · GWQ | 510(k) clearances |
| Jun 7, 1984 | EEG ELECTRODESK841685 · GXY | 510(k) clearances |
| Jun 7, 1984 | BIO/SCAN BIOLOG CASSETTE RECORDERK841684 · GWQ | 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
