Vidar Systems Corp.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Vidar Systems Corp.” (first 1993, latest 2013), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 76 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 | 2 | 78 |
| 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 |
|---|---|---|---|
| LMA | Digitizer, Image, Radiological | 10 | 10 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 2 | 2 |
| JAK | System, X-Ray, Tomography, Computed | 1 | 1 |
Review panels
- Radiology (13)
Most recent Vidar Systems Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130636 | TELERADPRO EDGE; TELERADPRO EDGE HD-CCD | LMA | 2013-06-07 | 88 |
| K130406 | DIAGNOSTICPRO EDGE | LMA | 2013-04-29 | 69 |
| K102476 | TELERADPRO | LMA | 2010-10-07 | 38 |
| K093809 | VIDAR DENTAL FILM DIGITIZER | LMA | 2010-01-07 | 29 |
| K071193 | VIDAR VISION 3000 AND 4000 X-RAY SYSTEMS | MQB | 2007-05-30 | 30 |
| K070563 | VIDAR VISION 2000 | MQB | 2007-03-16 | 17 |
| K024171 | VIDAR BONE TRACK SYSTEM SOFTWARE | JAK | 2003-03-04 | 76 |
| K011049 | EXPRESSSUITE | LMA | 2001-10-01 | 178 |
| K993598 | MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205 | LMA | 2000-01-20 | 87 |
| K993599 | DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMETRY PRO, MODEL 13019 | LMA | 2000-01-18 | 85 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Vidar Systems Corp..
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 Vidar Systems Corp.?
FDA lists 13 510(k) clearances under the applicant name “Vidar Systems Corp.” (first 1993, latest 2013), across 3 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 Vidar Systems Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vidar Systems Corp. is 76 days.
Which FDA product codes appear under Vidar Systems Corp.?
The most frequent FDA product codes under this applicant name are LMA (Digitizer, Image, Radiological, 10); MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 2); JAK (System, X-Ray, Tomography, Computed, 1).
Next steps
- See all 13 Vidar Systems Corp. clearances with predicates and recalls
- Run predicate analysis for product code LMA, Vidar Systems Corp.'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.