Volume Interactions Pte, Ltd.: FDA clearances and approvals
Volume Interactions Pte, Ltd. has 5 FDA 510(k) clearances (first 2002, latest 2007), across 1 product code in 1 review panel. Median 510(k) review time: 36 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 | 5 | 5 |
Review panels
- Radiology (5)
Most recent Volume Interactions Pte, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K071054 | RADIODEXTER, DEXTROSCOPE, DEXTROBEAM, MODELS 1.0, MK10, MK3 & MK4 | LLZ | 2007-05-22 | 36 |
| K063730 | DEXTROSCOPE, MODEL MK10; DEXTROBEAM, MODEL MK3, MK4; RADIODEXTER, MODEL 1.0 | LLZ | 2007-01-31 | 44 |
| K053162 | DEXTROSCOPE & DEXTROBEAM | LLZ | 2005-12-09 | 25 |
| K032924 | RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK3 | LLZ | 2003-10-10 | 18 |
| K022938 | VIZDEXTER VERSION 2.0; DEXTROSCOPE MK8; DEXTROBEAM MK3 | LLZ | 2002-10-25 | 51 |
Recalls
openFDA lists no recalls under a recalling firm named Volume Interactions Pte, Ltd..
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 Volume Interactions Pte, Ltd. have?
Volume Interactions Pte, Ltd. has 5 FDA 510(k) clearances (first 2002, latest 2007), across 1 product code in 1 review panel.
How long does FDA take to clear Volume Interactions Pte, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Volume Interactions Pte, Ltd.'s cleared 510(k)s is 36 days.
What devices does Volume Interactions Pte, Ltd. make?
Its most frequent FDA product codes are LLZ (System, Image Processing, Radiological, 5).
Has Volume Interactions Pte, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Volume Interactions Pte, Ltd. Related entities may recall under other names.
Next steps
- See all 5 Volume Interactions Pte, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Volume Interactions Pte, Ltd.'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.