Cti Pet Systems, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Cti Pet Systems, Inc.” (first 1991, latest 2005), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 61 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | 18 | 18 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Review panels
- Radiology (19)
Most recent Cti Pet Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K050509 | LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I | KPS | 2005-03-25 | 24 |
| K042467 | LSO PET/CT HIREZ 64 | KPS | 2004-10-01 | 18 |
| K040933 | ECAT HRRT | KPS | 2004-06-07 | 59 |
| K033431 | LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ | KPS | 2003-11-20 | 23 |
| K023768 | ECAT PET/CT; ECAT LSO PET/CT; ECAT LSO PET/CT 16 | KPS | 2002-11-25 | 13 |
| K023518 | ECAT LSO PET/CT 16 | KPS | 2002-11-08 | 18 |
| K021633 | ECAT VISION PET SCANNER, MODELS 3000 & 5000 | KPS | 2002-08-14 | 89 |
| K013504 | MODIFICATION TO: ECAT LSO PET/CT SCANNER | KPS | 2001-10-31 | 9 |
| K003241 | ECAT PET SCANNER | KPS | 2000-12-13 | 57 |
| K002584 | ECAT ACCEL PET SCANNER | KPS | 2000-11-16 | 87 |
9 earlier clearances. See the full list in Caduvo.
Recalls
4 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2005-04-05.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Cti Pet Systems, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Cti Pet Systems, Inc.” (first 1991, latest 2005), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cti Pet Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cti Pet Systems, Inc. is 61 days.
Which FDA product codes appear under Cti Pet Systems, Inc.?
The most frequent FDA product codes under this applicant name are KPS (System, Tomography, Computed, Emission, 18); LLZ (System, Image Processing, Radiological, 1).
Next steps
- See all 19 Cti Pet Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KPS, Cti Pet Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.