Ultraspect, Ltd.
Haifa, IL
Ultraspect , Ltd. appears in FDA device records in Haifa, IL. FDA records list 6 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 6
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 6 510(k) clearances for Ultraspect, Ltd. between 2004 and 2011. The busiest year on record is 2008, with 2. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 1 |
| 2005 | 1 |
| 2008 | 2 |
| 2009 | 1 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K103710 | WBR XPRESS PET | KPS | Substantially Equivalent | |
| K091073 | WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONS | KPS | Substantially Equivalent | |
| K081201 | WBR XPRESS3.CARDIAC | KPS | Substantially Equivalent | |
| K080784 | WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE | KPS | Substantially Equivalent | |
| K050815 | XACT.CARDIAC & XPRESS.CARDIAC | KPS | Substantially Equivalent | |
| K040370 | WBR-FHR, WBR-FWB | KPS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
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