Visualization Technology, Inc.: FDA clearances and approvals
Visualization Technology, Inc. has 7 FDA 510(k) clearances (first 1996, latest 2001), across 1 product code in 1 review panel. Median 510(k) review time: 80 days.
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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 7 | 7 |
Review panels
- Radiology (7)
Most recent Visualization Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K003510 | INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500 | LLZ | 2001-02-12 | 90 |
| K994270 | INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000 | LLZ | 2000-03-09 | 80 |
| K990919 | STRAIGHT ASPIRATOR, 90 DEGREE ASPIRATOR,45 DEGREE ASPIRATOR,7 FRENCH ASPIRATOR,EXTENDED STRAIGHT ASPIRATOR,13.9 CM STRAG | LLZ | 1999-04-15 | 28 |
| K983529 | INSTATRAK 3000 | LLZ | 1998-12-31 | 84 |
| K982994 | SKULL BASE INSTATRAK SYSTEM | LLZ | 1998-11-16 | 81 |
| K981998 | PEDIATRIC INSTATRAK SYSTEM | LLZ | 1998-08-21 | 74 |
| K960330 | INSTATRAK | LLZ | 1996-04-08 | 75 |
Recalls
openFDA lists no recalls under a recalling firm named Visualization Technology, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Visualization Technology, Inc. have?
Visualization Technology, Inc. has 7 FDA 510(k) clearances (first 1996, latest 2001), across 1 product code in 1 review panel.
How long does FDA take to clear Visualization Technology, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Visualization Technology, Inc.'s cleared 510(k)s is 80 days.
What devices does Visualization Technology, Inc. make?
Its most frequent FDA product codes are LLZ (System, Image Processing, Radiological, 7).
Has Visualization Technology, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Visualization Technology, Inc. Related entities may recall under other names.
Next steps
- See all 7 Visualization Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Visualization Technology, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.