Data / Medical devices / Israel / Aspect Imaging Ltd
Aspect Imaging Ltd: FDA-registered device maker in Shoham Tel Aviv, Israel, 1 510(k) clearance
Aspect Imaging Ltd is registered with the FDA (registration 3009714754) in Shoham Tel Aviv, Israel. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 19, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009714754
- Address
- 27 Skaked St. Industrial Area Hevel Modi"in, Shoham Tel Aviv, Israel, 6085001
- Owner or operator
- Aspect Imaging Ltd (10043635)
- Roles
- Manufacturer
- First device listed
- August 3, 2017
- Registered through
- 2026
- Brand names listed
- Embrace
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | MOS | 2 | Manufacturer | accessdata.fda.gov |
| 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 |
|---|---|---|---|---|---|---|
| July 19, 2017 | K170978 | Embrace Neonatal MRI System | LNH | Substantially Equivalent | Aspect Imaging, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Nuclear Magnetic Resonance Imaging
- All makers of Coil, Magnetic Resonance, Specialty
Updated July 19, 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.