Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bruker Medical Imaging, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
114 daysmedian FDA review time
190 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K915657 | MODIFIED MAGNETIC RESONANCE IMAGING SYTEM MOD. R28 | Bruker Medical Imaging, Inc. | 1992-03-13 | 86 | 0 |
| K913463 | MAG RES IMAG SYST/BRUKER MODEL R28 WHOLE BODY SCAN | Bruker Medical Imaging, Inc. | 1991-11-29 | 116 | 0 |
| K903661 | BRUKER R-28,HEAD AND CHEST ANGIOGRAPHY IMAGING ADD | Bruker Medical Imaging, Inc. | 1990-11-13 | 92 | 0 |
| K900026 | BRUKER R28 WHOLE-BODY MR SCANNER | Bruker Medical Imaging, Inc. | 1990-04-30 | 117 | 0 |
| K895328 | MAGNETIC RESONANCE SYSTEM MODEL BMT-1100 | Bruker Medical Imaging, Inc. | 1990-03-09 | 190 | 0 |
| K894714 | 1989 SOFTWARE REVISION TO THE BMT-1100 | Bruker Medical Imaging, Inc. | 1989-11-15 | 114 | 0 |
| K891760 | MAGNETIC RESONANCE SYSTEM, MODEL BMT 1100,MODIFIED | Bruker Medical Imaging, Inc. | 1989-06-23 | 92 | 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