Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Viztek, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
179 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102123 | VIZION DR | Viztek, Inc. | 2011-01-24 | 179 | 0 |
| K091752 | VIZTEK WL | Viztek, Inc. | 2009-11-12 | 149 | 0 |
| K082604 | VIZTEK DR, MODELS: DR1000, DR3000, DR4000 | Viztek, Inc. | 2008-11-21 | 74 | 0 |
| K063337 | OPAL-RAD | Viztek, Inc. | 2006-12-12 | 36 | 0 |
| K003607 | ONYX-RAD TELEMEDICINE PACS | Viztek, Inc. | 2001-02-15 | 85 | 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