Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Instrumentarium Corp. Imaging Division · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K043612 | ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D | Instrumentarium Corp. Imaging Division | 2005-02-09 | 41 | 0 |
| K023864 | PERFORMA STEREO | Instrumentarium Corp. Imaging Division | 2003-01-09 | 50 | 0 |
| K022275 | DELTA 32; DELTA 32 TACT | Instrumentarium Corp. Imaging Division | 2002-09-12 | 59 | 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