Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cti Pet Systems, Inc. — Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
61 daysmedian FDA review time
104 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050509 | LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I | Cti Pet Systems, Inc. | 2005-03-25 | 24 | 0 |
| K042467 | LSO PET/CT HIREZ 64 | Cti Pet Systems, Inc. | 2004-10-01 | 18 | 1 |
| K040933 | ECAT HRRT | Cti Pet Systems, Inc. | 2004-06-07 | 59 | 0 |
| K033431 | LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ | Cti Pet Systems, Inc. | 2003-11-20 | 23 | 1 |
| K023768 | ECAT PET/CT; ECAT LSO PET/CT; ECAT LSO PET/CT 16 | Cti Pet Systems, Inc. | 2002-11-25 | 13 | 0 |
| K023518 | ECAT LSO PET/CT 16 | Cti Pet Systems, Inc. | 2002-11-08 | 18 | 1 |
| K021633 | ECAT VISION PET SCANNER, MODELS 3000 & 5000 | Cti Pet Systems, Inc. | 2002-08-14 | 89 | 0 |
| K013504 | MODIFICATION TO: ECAT LSO PET/CT SCANNER | Cti Pet Systems, Inc. | 2001-10-31 | 9 | 2 |
| K003241 | ECAT PET SCANNER | Cti Pet Systems, Inc. | 2000-12-13 | 57 | 2 |
| K002584 | ECAT ACCEL PET SCANNER | Cti Pet Systems, Inc. | 2000-11-16 | 87 | 14 |
| K002715 | ECAT PET SCANNER | Cti Pet Systems, Inc. | 2000-10-31 | 61 | 2 |
| K002039 | ECAT PET SCANNER, MODELS ECAT EXACT AND ECAT EXACT HR+ AND E | Cti Pet Systems, Inc. | 2000-09-27 | 84 | 0 |
| K981027 | E.CAM LSO 311 PET/SPECT SYSTEM | Cti Pet Systems, Inc. | 1998-06-08 | 81 | 0 |
| K974256 | ECAT PET SCANNERS | Cti Pet Systems, Inc. | 1998-02-25 | 104 | 0 |
| K962797 | ECAT EXACT & ECAT EXACT HR+ | Cti Pet Systems, Inc. | 1996-10-15 | 89 | 14 |
| K940478 | ECAT PRT | Cti Pet Systems, Inc. | 1994-03-22 | 48 | 14 |
| K920624 | ECAT EXACT HR MODEL 961 | Cti Pet Systems, Inc. | 1992-04-27 | 76 | 1 |
| K913637 | ECAT SCANNER (MODEL 921) | Cti Pet Systems, Inc. | 1991-11-27 | 104 | 1 |
| K910048 | ECAT SCANNER | Cti Pet Systems, Inc. | 1991-05-17 | 130 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda