Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LNI — Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
85 daysmedian FDA review time
826 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K093044 | OASIS MRI SYSTEM | Hitachi Medical Systems America, Inc. | 2010-03-16 | 167 | 0 |
| K071506 | ECHELON SPECTROSCOPY PACKAGE | Hitachi Medical Systems America, Inc. | 2007-06-28 | 27 | 0 |
| K011604 | PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTI | Ge Medical Systems, Inc. | 2001-08-22 | 90 | 0 |
| K010129 | EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3 | Toshiba America Medical Systems, In.C | 2001-04-05 | 79 | 0 |
| K003575 | MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM | GE Medical Systems | 2001-01-17 | 58 | 0 |
| K991568 | MR SPECTROSCOPY PACKAGE | Philips Medical Systems (Cleveland), Inc. | 1999-07-19 | 75 | 0 |
| K984167 | SAGE 7 | GE Medical Systems | 1999-01-12 | 53 | 0 |
| K962627 | CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYST | Siemens Medical Solutions USA, Inc. | 1997-04-03 | 272 | 0 |
| K970005 | GYREX 2T-PRESTIGE | Elscint, Inc. | 1997-03-28 | 85 | 0 |
| K930265 | HYDROGEN SPECTROSCOPY OPTION-PROBE #M1040HS/HT | GE Medical Systems | 1995-04-25 | 826 | 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