Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

Vortech Data, Inc. — Predicate Candidate Screening

11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

99 daysmedian FDA review time
153 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K924366PERSONAL DISPLAY SYSTEMVortech Data, Inc.1993-04-072220
K925097VORTECH'S AUTOROUTER (AUTOMATIC IMAGE ROUTING)Vortech Data, Inc.1993-01-15990
K924229VG-A MIGVortech Data, Inc.1992-11-27980
K922310VORTECH'S PERSONAL DISPLAY SYSTEMVortech Data, Inc.1992-07-30730
K915362VORTECH'S FILM DIGITIZER, FD-1Vortech Data, Inc.1992-04-061310
K914834VORTECH 3M NETWORK PRINTINGVortech Data, Inc.1992-03-061330
K914444XPR PRINTER REDUNDANCYVortech Data, Inc.1992-02-271460
K914191XLP NETWORK PRINTINGVortech Data, Inc.1992-02-181530
K915094VORTECH'S IMAGE ARCHIVAL AND RETRIEVAL SYSTEMVortech Data, Inc.1991-12-27450
K913491VORTECH'S PERSONAL DISPLAY SYSTEMVortech Data, Inc.1991-09-06310
K884434VORTECH'S MEDICAL IMAGING GATEWAYVortech Data, Inc.1989-01-19910

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