Data / Medical devices / United States / Sonomed, Inc.
Sonomed, Inc.: FDA-registered device maker in Westbury, NY, United States, 6 510(k) clearances
Sonomed, Inc. is registered with the FDA (registration 2433682) in Westbury, NY, United States. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated May 2, 2017. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 2433682
- Address
- 865 Merrick Ave Ste 30s, Westbury, NY, United States, 11590
- Owner or operator
- SONOMED, INC. (2433682)
- Roles
- Manufacturer
- First device listed
- July 2, 1992
- Registered through
- 2026
- Brand names listed
- AXIS Image Management System, Direct Contact A-Probe, Immersion A-Probe, MV5600, Master-Vu A-Scan System, Master-Vu B-Scan, PacScan 300A+, PacScan 300AP+ and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Scintillation (Gamma) | IYX | 1 | Manufacturer | accessdata.fda.gov |
| System, Image Management, Ophthalmic | NFJ | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 2, 2017 | K171098 | AXIS Image Management System | NFJ | Substantially Equivalent | Sonomed, Inc. | accessdata.fda.gov |
| April 1, 2014 | K140199 | VUPAD | IYO | Substantially Equivalent | Sonomed, Inc. | accessdata.fda.gov |
| April 9, 2010 | K100252 | MASTER-VU A-SCAN, MV4500 | IYO | Substantially Equivalent | Sonomed, Inc. | accessdata.fda.gov |
| September 24, 2009 | K092637 | PACSCAN PLUS, MODELS 300P AND 300AP | ITX | Substantially Equivalent | Sonomed, Inc. | accessdata.fda.gov |
| December 19, 2007 | K073196 | MASTER-VU | IYO | Substantially Equivalent | Sonomed, Inc. | accessdata.fda.gov |
| April 11, 2006 | K060626 | VUMAX | IYO | Substantially Equivalent | Sonomed, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of Camera, Scintillation (Gamma)
- All makers of System, Image Management, Ophthalmic
Updated May 2, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.