Aspect Imaging Ltd
Shoham Tel Aviv, IL
ASPECT IMAGING LTD appears in FDA device records in Shoham Tel Aviv, IL. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Aspect Imaging Ltd between 2013 and 2026. The busiest year on record is 2013, with 1. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2014 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254277 | Embrace Neonatal MRI System | LNH | Substantially Equivalent | |
| K170978 | Embrace Neonatal MRI System | LNH | Substantially Equivalent | |
| K160185 | Wrist 3 | LNH | Substantially Equivalent | |
| K130692 | M2 WRIST 2 MRI SYSTEM | LNH | Substantially Equivalent | |
| K120701 | M2 WRIST MRI SYSTEM | LNH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009714754 | 3009714754 | ASPECT IMAGING LTD | 27 Skaked St. Industrial Area Hevel Modi"in, Shoham Tel Aviv 6085001 IL | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain