Techsomed Medical Technologies , Ltd.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Techsomed Medical Technologies , Ltd.” (first 2024, latest 2025), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 82 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 |
|---|---|---|
| 2024 | 1 | 88 |
| 2025 | 1 | 76 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Techsomed Medical Technologies , Ltd. took a median 82 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 252 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QZL | Post-Ablation Tissue Response Prediction Software | 2 | 1 |
| QTZ | Radiological Image Processing Software For Ablation Therapy Planning And Evaluation | 1 | 1 |
Review panels
- Radiology (3)
Most recent Techsomed Medical Technologies , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251931 | BioTraceIO Vision (V1.7) | QTZ | 2025-09-08 | 76 |
| K243084 | BioTraceIO Precision (2.0) | QZL | 2024-12-27 | 88 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN230020 | De Novo | Post-Ablation Tissue Response Prediction Software | 2023-12-22 |
Recalls
openFDA lists no recalls under a recalling firm named Techsomed Medical Technologies , Ltd..
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.
Device clinical trials
An industry sponsor named Techsomed Medical Technologies , Ltd. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04970212: Safety and Effectiveness of BioTraceIO Lite for Tissue Damage Assessment Following Liver Tissue Ablation Procedures (Completed, started 2021-09-24)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Techsomed (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Techsomed Medical Technologies , Ltd.?
FDA lists 2 510(k) clearances under the applicant name “Techsomed Medical Technologies , Ltd.” (first 2024, latest 2025), plus 1 De Novo decision, across 2 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 Techsomed Medical Technologies , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Techsomed Medical Technologies , Ltd. is 82 days.
Which FDA product codes appear under Techsomed Medical Technologies , Ltd.?
The most frequent FDA product codes under this applicant name are QZL (Post-Ablation Tissue Response Prediction Software, 2); QTZ (Radiological Image Processing Software For Ablation Therapy Planning And Evaluation, 1).
Next steps
- See all 2 Techsomed Medical Technologies , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code QZL, Techsomed Medical Technologies , Ltd.'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.