Viztek, LLC: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Viztek, LLC” (first 2001, latest 2016), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 69 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 | 1 | 46 |
| 2014 | 2 | 118 |
| 2015 | 1 | 29 |
| 2016 | 1 | 57 |
| 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 |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 5 | 5 |
| KPR | System, X-Ray, Stationary | 3 | 3 |
| LLZ | System, Image Processing, Radiological | 3 | 3 |
Review panels
- Radiology (11)
Most recent Viztek, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K160810 | ViZion DR + Wireless | MQB | 2016-05-20 | 57 |
| K152279 | ViZion DR + Wireless | MQB | 2015-09-10 | 29 |
| K142919 | EXA | LLZ | 2014-12-16 | 69 |
| K133139 | VIZION ULTRA | MQB | 2014-04-03 | 168 |
| K123644 | VIZION + DR | MQB | 2013-01-11 | 46 |
| K112661 | VIZION DR | MQB | 2011-10-20 | 37 |
| K102123 | VIZION DR | KPR | 2011-01-24 | 179 |
| K091752 | VIZTEK WL | KPR | 2009-11-12 | 149 |
| K082604 | VIZTEK DR, MODELS: DR1000, DR3000, DR4000 | KPR | 2008-11-21 | 74 |
| K063337 | OPAL-RAD | LLZ | 2006-12-12 | 36 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Viztek, LLC.
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 Viztek, LLC?
FDA lists 11 510(k) clearances under the applicant name “Viztek, LLC” (first 2001, latest 2016), 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 Viztek, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Viztek, LLC is 69 days.
Which FDA product codes appear under Viztek, LLC?
The most frequent FDA product codes under this applicant name are MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 5); KPR (System, X-Ray, Stationary, 3); LLZ (System, Image Processing, Radiological, 3).
Next steps
- See all 11 Viztek, LLC clearances with predicates and recalls
- Run predicate analysis for product code MQB, Viztek, LLC'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.