Data / Medical devices / Israel / Optoacoustics Ltd.
Optoacoustics Ltd.: FDA-registered device maker in Mazor Central, Israel, 1 510(k) clearance
Optoacoustics Ltd. is registered with the FDA (registration 3005976071) in Mazor Central, Israel. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 24, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005976071
- Address
- 17 Hanotea St., Mazor Central, Israel, 73160
- Owner or operator
- Optoacoustics Ltd. (10048918)
- Roles
- Manufacturer
- First device listed
- March 19, 2015
- Registered through
- 2026
- Brand names listed
- System, nuclear magnetic resonance imaging
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Nuclear Magnetic Resonance Imaging | LNH | 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 24, 2012 | K121239 | MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE | LNH | Substantially Equivalent | Optoacoustics, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 24, 2012. 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.