Seno Medical Instruments, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Seno Medical Instruments, Inc.” (first 2019, latest 2019), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 162 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 |
|---|---|---|
| 2019 | 1 | 162 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Seno Medical Instruments, Inc. took a median 162 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 101 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 | 1 |
| QNK | Optoacoustic Imaging System | 1 | 0 |
Review panels
- Radiology (2)
Most recent Seno Medical Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K182628 | Imagio Ultrasound Imaging System | IYN | 2019-03-05 | 162 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P200003 | PMA | Imagio Breast Imaging System | 2021-01-11 |
Recalls
openFDA lists no recalls under a recalling firm named Seno Medical Instruments, 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.
Device clinical trials
An industry sponsor named Seno Medical Instruments, Inc. is the lead sponsor of 7 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05022602: Clinical Evaluation of Opto-Acoustic Image Quality With the Gen 2 Imagio System (Completed, started 2021-08-19)
- NCT05337280: OA for Breast Cancer NAC Response (Completed, started 2021-03-30)
- NCT05084729: CONFIDENCE Registry (Completed, started 2020-09-11)
- NCT04030104: Optoacoustic Images Versus Imagio® Ultrasound (Completed, started 2019-07-30)
- NCT03708393: Imagio Feasibility Multi-Reader, Multi-Case Study (Completed, started 2018-11-13)
Frequently asked questions
How many FDA 510(k) clearances are listed under Seno Medical Instruments, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Seno Medical Instruments, Inc.” (first 2019, latest 2019), plus 1 PMA 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 Seno Medical Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Seno Medical Instruments, Inc. is 162 days.
Which FDA product codes appear under Seno Medical Instruments, Inc.?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 1); QNK (Optoacoustic Imaging System, 1).
Next steps
- See all 1 Seno Medical Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYN, Seno Medical Instruments, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.