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 Siemens HealthineersLabelled 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 CTI PET Systems, Inc. with 19 510(k) clearances. The most recent is a 510(k) clearance dated Mar 25, 2005: LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I.
| Mar 25, 2005 | LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64IK050509 · KPS | 510(k) clearances |
| Oct 1, 2004 | LSO PET/CT HIREZ 64K042467 · KPS | 510(k) clearances |
| Jun 7, 2004 | ECAT HRRTK040933 · KPS | 510(k) clearances |
| Nov 20, 2003 | LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZK033431 · KPS | 510(k) clearances |
| Nov 25, 2002 | ECAT PET/CT; ECAT LSO PET/CT; ECAT LSO PET/CT 16K023768 · KPS | 510(k) clearances |
| Nov 8, 2002 | ECAT LSO PET/CT 16K023518 · KPS | 510(k) clearances |
| Aug 14, 2002 | ECAT VISION PET SCANNER, MODELS 3000 & 5000K021633 · KPS | 510(k) clearances |
| Oct 31, 2001 | MODIFICATION TO: ECAT LSO PET/CT SCANNERK013504 · KPS | 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
