Trionix Research Laboratory, Inc.
Twinsburg, OH, US
Trionix Research Laboratory, Inc. appears in FDA device records in Twinsburg, OH. FDA records list 16 510(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 16 510(k) clearances for Trionix Research Laboratory, Inc. between 1988 and 1997. The busiest year on record is 1996, with 6. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 1 |
| 1989 | 1 |
| 1991 | 3 |
| 1992 | 4 |
| 1996 | 6 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K964438 | 511 KEV COLLIMATOR | KPS | Substantially Equivalent | |
| K962481 | QUASAR RECOVERY IMAGING PACKAGE | KPS | Substantially Equivalent | |
| K964268 | TRIAD 88 NUCLEAR IMAGING SYSTEM | KPS | Substantially Equivalent | |
| K964267 | MONAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM | KPS | Substantially Equivalent | |
| K964266 | BIAD NUCLEAR IMAGING SYSTEM | KPS | Substantially Equivalent | |
| K964265 | CARDIAC TRIAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM | KPS | Substantially Equivalent | |
| K961597 | GATED MIBI 3-D EJECTION FRACTION PROCESSING | KPS | Substantially Equivalent | |
| K923345 | BIAD NEW DETECTOR OPTION | KPS | Substantially Equivalent | |
| K923151 | CARDIAC TRIAD NEW DETECTOR OPTION | KPS | Substantially Equivalent | |
| K923044 | MONAD NUCLEAR IMAGING SYSTEM | KPS | Substantially Equivalent | |
| K920776 | CARDIAC TRIAD NUCLEAR IMAGING SYSTEM | KPS | Substantially Equivalent | |
| K912177 | VISIONPRO | KPS | Substantially Equivalent | |
| K912176 | ACQUPRO | KPS | Substantially Equivalent | |
| K911290 | EAGLE NUCLEAR IMAGING SYSTEM | KPS | Substantially Equivalent | |
| K892875 | BIAD NUCLEAR IMAGING SYSTEM | KPS | Substantially Equivalent | |
| K873775 | TRIAD NUCLEAR IMAGING SYSTEM | KPS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0193-2007 | BIAD Classic 24 (24 inch collimator). The collimator is a component of the Trionix Biad Full Imaging System. | The ball screw on the unit which supports the detector head (which weighs approximately 800 lbs.) could snap resulting in the detector head dropping on the patient. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain