Ultrasonix Medical Corporation: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Ultrasonix Medical Corporation” (first 2002, latest 2013), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 43 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 | 2 | 197 |
| 2013 | 1 | 530 |
| 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 |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 8 | 8 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 1 | 1 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
Review panels
- Radiology (10)
- Anesthesiology (1)
Most recent Ultrasonix Medical Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K121812 | SONIXGPS | BSP | 2013-12-02 | 530 |
| K111818 | SONIXGPS NEEDLE SENSOR | IYO | 2012-06-13 | 351 |
| K113663 | SONIXTABLET ULTRASOUND SCANNER | IYN | 2012-01-25 | 43 |
| K112726 | SONIX ULTRASOUND SCANNER | IYN | 2011-09-27 | 7 |
| K102997 | SONIXTABLET ULTRASOUND SCANNER | IYN | 2010-12-21 | 75 |
| K093462 | SONIX ULTRASOUND SCANNER | ITX | 2009-11-20 | 14 |
| K083095 | SONIXTOUCH ULTRASOUND SYSTEM | IYN | 2008-10-31 | 14 |
| K080935 | SONIX MDP ULTRASOUND SCANNER | IYN | 2008-08-06 | 126 |
| K061827 | SONIX ULTRASOUND SCANNER | IYN | 2006-08-04 | 37 |
| K042326 | ERGOSONIX ULTRASOUND SCANNER, MODULO ULTRASOUND SCANNER | IYN | 2004-09-16 | 20 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ultrasonix Medical Corporation.
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.
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.
- Ultrasonix, Inc. (2 510(k)s)
- Ultrasonix Medical Corpation (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ultrasonix Medical Corporation?
FDA lists 11 510(k) clearances under the applicant name “Ultrasonix Medical Corporation” (first 2002, latest 2013), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ultrasonix Medical Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ultrasonix Medical Corporation is 43 days.
Which FDA product codes appear under Ultrasonix Medical Corporation?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 8); BSP (Needle, Conduction, Anesthetic (W/Wo Introducer), 1); ITX (Transducer, Ultrasonic, Diagnostic, 1).
Next steps
- See all 11 Ultrasonix Medical Corporation clearances with predicates and recalls
- Run predicate analysis for product code IYN, Ultrasonix Medical Corporation'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.