Vortech Data, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Vortech Data, Inc.” (first 1989, latest 1993), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 99 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 |
|---|---|---|---|
| LMD | System, Digital Image Communications, Radiological | 5 | 5 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
| JAK | System, X-Ray, Tomography, Computed | 1 | 1 |
| KPR | System, X-Ray, Stationary | 1 | 1 |
| LMB | Device, Digital Image Storage, Radiological | 1 | 1 |
| LMC | Camera, Multi Format, Radiological | 1 | 1 |
Review panels
- Radiology (11)
Most recent Vortech Data, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K924366 | PERSONAL DISPLAY SYSTEM | LLZ | 1993-04-07 | 222 |
| K925097 | VORTECH'S AUTOROUTER (AUTOMATIC IMAGE ROUTING) | LMD | 1993-01-15 | 99 |
| K924229 | VG-A MIG | LMD | 1992-11-27 | 98 |
| K922310 | VORTECH'S PERSONAL DISPLAY SYSTEM | LLZ | 1992-07-30 | 73 |
| K915362 | VORTECH'S FILM DIGITIZER, FD-1 | KPR | 1992-04-06 | 131 |
| K914834 | VORTECH 3M NETWORK PRINTING | LMC | 1992-03-06 | 133 |
| K914444 | XPR PRINTER REDUNDANCY | LMD | 1992-02-27 | 146 |
| K914191 | XLP NETWORK PRINTING | LMD | 1992-02-18 | 153 |
| K915094 | VORTECH'S IMAGE ARCHIVAL AND RETRIEVAL SYSTEM | LMB | 1991-12-27 | 45 |
| K913491 | VORTECH'S PERSONAL DISPLAY SYSTEM | JAK | 1991-09-06 | 31 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Vortech Data, Inc..
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 Vortech Data, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Vortech Data, Inc.” (first 1989, latest 1993), across 6 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 Vortech Data, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vortech Data, Inc. is 99 days.
Which FDA product codes appear under Vortech Data, Inc.?
The most frequent FDA product codes under this applicant name are LMD (System, Digital Image Communications, Radiological, 5); LLZ (System, Image Processing, Radiological, 2); JAK (System, X-Ray, Tomography, Computed, 1).
Next steps
- See all 11 Vortech Data, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LMD, Vortech Data, 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.