Gvi Technology Partners
Twinsburg, OH, US
Gvi Technology Partners appears in FDA device records in Twinsburg, OH. FDA records list 3 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Gvi Technology Partners between 2003 and 2007. The busiest year on record is 2003, with 1. The most recent is 2007, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2005 | 1 |
| 2007 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K072191 | CLEARVISION NUCLEAR MEDICINE IMAGING SYSTEM | KPS | Substantially Equivalent | |
| K051402 | ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM | IYX | Substantially Equivalent | |
| K023373 | ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101 | IYX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0527-04 | CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version B1A, marketed by CDL Medical Tech. | Due to limitations in the operating software, the acquired scan may not be processed properly. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain