Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in NetherlandsLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of PIE Medical ImagingLabelled 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 15, 2026, FDA's public records list Pie Medical with 12 510(k) clearances. The most recent is a 510(k) clearance dated Sep 6, 2006: ART LAB SOFTWARE.
| Sep 6, 2006 | ART LAB SOFTWAREK061961 · LLZ | 510(k) clearances |
| Dec 16, 2005 | MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEMK053154 · IYN | 510(k) clearances |
| Jan 25, 2005 | MYLAB 15 / MYLAB 20, MODEL 2700K043588 · IYN | 510(k) clearances |
| Jan 5, 2005 | IMT.LABK043360 · LLZ | 510(k) clearances |
| Jul 23, 2004 | PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMSK041675 · IYN | 510(k) clearances |
| Dec 15, 2003 | TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50LK033604 · IYO | 510(k) clearances |
| Jan 24, 2003 | PICUS ULTRASOUND IMAGING SYSTEMSK023512 · IYN | 510(k) clearances |
| Apr 19, 2002 | 50S TRINGA ULTRASOUND IMAGING SYSTEMK020112 · IYO | 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
