Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Virtual Imaging, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
66 daysmedian FDA review time
112 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K093688 | CANON, MODEL URS-50RF | Virtual Imaging, Inc. | 2010-02-04 | 66 | 0 |
| K092439 | CANON DIGITAL FLUOROSCOPY AND RADIOGRAPHY, MODEL CXDI-50RF | Virtual Imaging, Inc. | 2009-11-30 | 112 | 0 |
| K092280 | CYPHER DICOM PRINT SOLUTION | Virtual Imaging, Inc. | 2009-10-16 | 80 | 0 |
| K083725 | RADPRO ION | Virtual Imaging, Inc. | 2009-01-22 | 38 | 0 |
| K070390 | FLUOROPRO RF DIGITAL IMAGING SYSTEM | Virtual Imaging, Inc. | 2007-04-05 | 55 | 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