Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
R2 Technology, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
14 daysmedian FDA review time
72 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K051743 | R2 BREAST IMAGING WORKSTATION | R2 Technology, Inc. | 2005-07-25 | 26 | 0 |
| K050667 | R2 FAMILY OF IMAGE DISPLAY UNITS WITH R2 UNIFORM DISPLAY SOF | R2 Technology, Inc. | 2005-03-29 | 14 | 0 |
| K041380 | IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICAT | R2 Technology, Inc. | 2004-06-08 | 14 | 0 |
| K040028 | CA-1500 | R2 Technology, Inc. | 2004-01-22 | 14 | 0 |
| K023003 | IMAGECHECKER-CT WORKSTATION | R2 Technology, Inc. | 2002-11-20 | 72 | 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