Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Perspectum — 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) |
|---|---|---|---|---|---|
| K233930 | MRCP+ version 2 (MRCP+ v2) | Perspectum | 2024-03-13 | 90 | 0 |
| K230294 | CoverScan (CoverScan v1.1) | Perspectum | 2023-03-03 | 29 | 0 |
| K213960 | LiverMultiScan v5 (LMSv5) | Perspectum | 2022-09-06 | 263 | 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