Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ramsoft, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
93 daysmedian FDA review time
146 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222476 | OmegaAI Image Viewer | Ramsoft, Inc. | 2022-11-17 | 93 | 0 |
| K141881 | RAPIDRESULTS | Ramsoft, Inc. | 2014-10-31 | 112 | 0 |
| K052460 | POWERSERVER, POWERREADER, GATEWAY AND POWERCACHE | Ramsoft, Inc. | 2005-09-21 | 14 | 0 |
| K031562 | RAMSOFT PACS, MODEL 3.0 | Ramsoft, Inc. | 2003-08-11 | 84 | 0 |
| K982563 | ULTRAPRO MODEL 98 | Ramsoft, Inc. | 1998-10-06 | 75 | 0 |
| K942917 | ULTRAPRO WORKSTATION | Ramsoft, Inc. | 1994-11-14 | 146 | 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