Cardiovascular Imaging Technologies: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Cardiovascular Imaging Technologies” (first 2004, latest 2020), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 31 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 | 1 | 89 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 145 |
| 2017 | 0 | — |
| 2018 | 1 | 57 |
| 2019 | 0 | — |
| 2020 | 1 | 29 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cardiovascular Imaging Technologies took a median 43 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 117 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | 6 | 6 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Review panels
- Radiology (7)
Most recent Cardiovascular Imaging Technologies 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201933 | ImagenSPECT 3.0 | KPS | 2020-08-11 | 29 |
| K173547 | ImagenUniversal | KPS | 2018-01-12 | 57 |
| K152503 | ImagenSPECT | KPS | 2016-01-25 | 145 |
| K122241 | IMAGEN3D | KPS | 2012-10-24 | 89 |
| K080770 | IMAGENMD WITH IMAGENQ | LLZ | 2008-04-09 | 22 |
| K050366 | IMAGENPRO | KPS | 2005-03-17 | 31 |
| K041671 | IMAGENMD | KPS | 2004-07-22 | 31 |
Recalls
openFDA lists no recalls under a recalling firm named Cardiovascular Imaging Technologies.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Cardiovascular Systems, Inc. (26 510(k)s)
- Cardiovascular Imaging Systems, Inc. (19 510(k)s)
- Cardiovascular Diagnostics, Inc. (13 510(k)s)
- Cardiovascular Dynamics, Inc. (11 510(k)s)
- Cardiovascular Devices, Inc. (8 510(k)s)
- Cardiovascular Diagnostic Services (8 510(k)s)
- Cardiovascular Research, Inc. (2 510(k)s)
- Cardiovascular Systems Incorporated (2 510(k)s)
- Cardiovascular Group, Inc. (1 510(k)s)
- Cardiovascular Imaging Solutions , Ltd. (1 510(k)s)
- Cardiovascular Innovations (1 510(k)s)
- Cardiovascular System, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cardiovascular Imaging Technologies?
FDA lists 7 510(k) clearances under the applicant name “Cardiovascular Imaging Technologies” (first 2004, latest 2020), 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 Cardiovascular Imaging Technologies?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cardiovascular Imaging Technologies is 31 days.
Which FDA product codes appear under Cardiovascular Imaging Technologies?
The most frequent FDA product codes under this applicant name are KPS (System, Tomography, Computed, Emission, 6); LLZ (System, Image Processing, Radiological, 1).
Next steps
- See all 7 Cardiovascular Imaging Technologies clearances with predicates and recalls
- Run predicate analysis for product code KPS, Cardiovascular Imaging Technologies'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.