Tecnomed, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Tecnomed, Inc.” (first 1978, latest 1989), across 11 product codes in 1 review panel. Median 510(k) review time under this name: 29 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 | 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 |
|---|---|---|---|
| IXQ | Table, Radiographic, Stationary Top | 2 | 2 |
| IXR | Table, Radiographic, Tilting | 2 | 2 |
| IYB | Tube Mount, X-Ray, Diagnostic | 2 | 2 |
| IZF | System, X-Ray, Tomographic | 2 | 2 |
| KPW | Device, Beam Limiting, X-Ray, Diagnostic | 2 | 2 |
| IWX | Barrier, Control Panel, X-Ray, Movable | 1 | 1 |
| IZH | System, X-Ray, Mammographic | 1 | 1 |
| IZL | System, X-Ray, Mobile | 1 | 1 |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 1 | 1 |
| KXJ | Table, Radiologic | 1 | 1 |
Plus 1 more product codes.
Review panels
- Radiology (15)
Most recent Tecnomed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K892226 | TEC 6340 90/15 RADIOGRAPHIC/FLUOROSCOPIC TABLE | IXR | 1989-04-26 | 22 |
| K854203 | TEC 2720 MAMEX DC MAG | IZH | 1986-03-06 | 141 |
| K827126 | TECHNOMED GENERATOR, RADIOGRAPHIC, 3 PHASE | — | 1982-03-05 | 29 |
| K827124 | RALCO COLLIMATOR, AUTOMATIC, RADIOGRAPHIC | — | 1982-03-05 | 29 |
| K820307 | TECNOMED GENERATOR, RADIOGRAPH., 3 PHASE | IZO | 1982-03-05 | 29 |
| K820306 | RALCO COLLIMATOR, AUTOMATIC RADIOGRAPHIC | KPW | 1982-03-05 | 29 |
| K827125 | RALCO COLLIMATORS, MANUAL, RADIOGRAPHIC | — | 1982-03-04 | 28 |
| K820305 | RALCO COLLIMATORS, MANUAL RADIOGRAPHIC | KPW | 1982-03-04 | 28 |
| K811197 | SUPERIX 120 | IZF | 1981-06-09 | 40 |
| K811196 | ALLMEC 90/15 | KXJ | 1981-06-09 | 40 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Tecnomed, Inc..
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 Tecnomed, Inc.?
FDA lists 18 510(k) clearances under the applicant name “Tecnomed, Inc.” (first 1978, latest 1989), across 11 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 Tecnomed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tecnomed, Inc. is 29 days.
Which FDA product codes appear under Tecnomed, Inc.?
The most frequent FDA product codes under this applicant name are IXQ (Table, Radiographic, Stationary Top, 2); IXR (Table, Radiographic, Tilting, 2); IYB (Tube Mount, X-Ray, Diagnostic, 2).
Next steps
- See all 18 Tecnomed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IXQ, Tecnomed, Inc.'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.