Company ยท US
Trionix Research Laboratory, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 1997. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KPS | System, Tomography, Computed, Emission | 17 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 29, 1997 | K964438 | 511 KEV COLLIMATOR Trionix Research Laboratory, Inc. | KPS |
| Nov 27, 1996 | K962481 | QUASAR RECOVERY IMAGING PACKAGE Trionix Research Laboratory, Inc. | KPS |
| Nov 12, 1996 | K964268 | TRIAD 88 NUCLEAR IMAGING SYSTEM Trionix Research Laboratory, Inc. | KPS |
| Nov 12, 1996 | K964267 | MONAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM Trionix Research Laboratory, Inc. | KPS |
| Nov 12, 1996 | K964266 | BIAD NUCLEAR IMAGING SYSTEM Trionix Research Laboratory, Inc. | KPS |
| Nov 12, 1996 | K964265 | CARDIAC TRIAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM Trionix Research Laboratory, Inc. | KPS |
| Sep 4, 1996 | K961597 | GATED MIBI 3-D EJECTION FRACTION PROCESSING Trionix Research Laboratory, Inc. | KPS |
| Sep 10, 1992 | K923345 | BIAD NEW DETECTOR OPTION Trionix Research Laboratory, Inc. | KPS |
| Sep 10, 1992 | K923151 | CARDIAC TRIAD NEW DETECTOR OPTION Trionix Research Laboratory, Inc. | KPS |
| Aug 27, 1992 | K923044 | MONAD NUCLEAR IMAGING SYSTEM Trionix Research Laboratory, Inc. | KPS |
| Apr 27, 1992 | K920776 | CARDIAC TRIAD NUCLEAR IMAGING SYSTEM Trionix Research Laboratory, Inc. | KPS |
| Sep 6, 1991 | K912177 | VISIONPRO Trionix Research Laboratory, Inc. | KPS |
| Sep 6, 1991 | K912176 | ACQUPRO Trionix Research Laboratory, Inc. | KPS |
| Aug 19, 1991 | K911290 | EAGLE NUCLEAR IMAGING SYSTEM Trionix Research Laboratory, Inc. | KPS |
| Jul 20, 1989 | K892875 | BIAD NUCLEAR IMAGING SYSTEM Trionix Research Laboratory, Inc. | KPS |
| Jan 19, 1988 | K873775 | TRIAD NUCLEAR IMAGING SYSTEM Trionix Research Laboratory, Inc. | KPS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 16, 2006 | Trionix Research Laboratory Inc BIAD Classic 24 (24 inch collimator). The collimator is a component of the Trionix Biad Full Imaging System. Terminated |
KPS | K892875 |