Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Trionix Research Laboratory, Inc. · Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
92 daysmedian FDA review time
154 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964438 | 511 KEV COLLIMATOR | Trionix Research Laboratory, Inc. | 1997-05-29 | 205 | 0 |
| K962481 | QUASAR RECOVERY IMAGING PACKAGE | Trionix Research Laboratory, Inc. | 1996-11-27 | 154 | 0 |
| K964268 | TRIAD 88 NUCLEAR IMAGING SYSTEM | Trionix Research Laboratory, Inc. | 1996-11-12 | 19 | 0 |
| K964267 | MONAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGR | Trionix Research Laboratory, Inc. | 1996-11-12 | 19 | 0 |
| K964265 | CARDIAC TRIAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTE | Trionix Research Laboratory, Inc. | 1996-11-12 | 19 | 0 |
| K964266 | BIAD NUCLEAR IMAGING SYSTEM | Trionix Research Laboratory, Inc. | 1996-11-12 | 19 | 0 |
| K961597 | GATED MIBI 3-D EJECTION FRACTION PROCESSING | Trionix Research Laboratory, Inc. | 1996-09-04 | 133 | 0 |
| K923345 | BIAD NEW DETECTOR OPTION | Trionix Research Laboratory, Inc. | 1992-09-10 | 78 | 0 |
| K923151 | CARDIAC TRIAD NEW DETECTOR OPTION | Trionix Research Laboratory, Inc. | 1992-09-10 | 78 | 0 |
| K923044 | MONAD NUCLEAR IMAGING SYSTEM | Trionix Research Laboratory, Inc. | 1992-08-27 | 64 | 0 |
| K920776 | CARDIAC TRIAD NUCLEAR IMAGING SYSTEM | Trionix Research Laboratory, Inc. | 1992-04-27 | 67 | 0 |
| K912177 | VISIONPRO | Trionix Research Laboratory, Inc. | 1991-09-06 | 113 | 0 |
| K912176 | ACQUPRO | Trionix Research Laboratory, Inc. | 1991-09-06 | 113 | 0 |
| K911290 | EAGLE NUCLEAR IMAGING SYSTEM | Trionix Research Laboratory, Inc. | 1991-08-19 | 147 | 0 |
| K892875 | BIAD NUCLEAR IMAGING SYSTEM | Trionix Research Laboratory, Inc. | 1989-07-20 | 92 | 1 |
| K873775 | TRIAD NUCLEAR IMAGING SYSTEM | Trionix Research Laboratory, Inc. | 1988-01-19 | 125 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda