Vital Images, Inc.: FDA filings under this applicant name
FDA lists 41 510(k) clearances under the applicant name “Vital Images, Inc.” (first 1995, latest 2018), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 51 days. Since 2017 the median was 38 days, against 127 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Canon Medical Systems, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 124 |
| 2013 | 1 | 186 |
| 2014 | 3 | 74 |
| 2015 | 6 | 62 |
| 2016 | 3 | 55 |
| 2017 | 3 | 38 |
| 2018 | 2 | 108 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 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 Vital Images, Inc. took a median 38 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 127 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 34 | 34 |
| JAK | System, X-Ray, Tomography, Computed | 7 | 7 |
Review panels
- Radiology (41)
Most recent Vital Images, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K181247 | Vitrea CT Brain Perfusion | LLZ | 2018-11-20 | 194 |
| K182230 | Multi Modality Viewer | LLZ | 2018-09-07 | 21 |
| K172855 | Vitrea Advanced Visualization, Version 7.6 | LLZ | 2017-10-05 | 15 |
| K163232 | Vitrea View | LLZ | 2017-07-21 | 246 |
| K163574 | Multi Modality Viewer | LLZ | 2017-01-26 | 38 |
| K161157 | Vitrea CT Dual Energy Image View | JAK | 2016-11-03 | 192 |
| K161419 | Multi Modality Viewer | LLZ | 2016-07-13 | 51 |
| K160150 | Vitrea CT Colon Analysis | LLZ | 2016-03-16 | 55 |
| K151283 | Lung Analysis Software | JAK | 2015-10-30 | 169 |
| K151919 | Vitrea CT Lung Density Analysis Software | JAK | 2015-10-10 | 89 |
31 earlier clearances. See the full list in Caduvo.
Recalls
10 product recalls in 10 recall events; 0 initiated in the last five years. Most recent: 2013-10-21.
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.
- Vital Signs, Inc. (75 510(k)s)
- Vital Metrics, Inc. (9 510(k)s)
- Vital Diagnostics (Manufacturing) Ptyltd (5 510(k)s)
- Vital Scientific N.V. (5 510(k)s)
- Vital Concepts, Inc. (4 510(k)s)
- Vital Art and Science Incorporated (2 510(k)s)
- Vital Connections, Inc. (2 510(k)s)
- Vital Signs, Inc., A GE Healthcare Company (2 510(k)s)
- Vital 5 (1 510(k)s)
- Vital Access (1 510(k)s)
- Vital Air Oxygen Co. (1 510(k)s)
- Vital Canada, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Vital Images, Inc.?
FDA lists 41 510(k) clearances under the applicant name “Vital Images, Inc.” (first 1995, latest 2018), 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 Vital Images, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vital Images, Inc. is 51 days. Since 2017: 38 days, versus 127 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Vital Images, Inc.?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 34); JAK (System, X-Ray, Tomography, Computed, 7).
Next steps
- See all 41 Vital Images, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Vital Images, 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.