Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

E-Woo Technology — Predicate Candidate Screening

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

97 daysmedian FDA review time
480 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K091090DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL XMARU 1717E-Woo Technology2010-08-094800
K090526MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSORE-Woo Technology2009-12-022790
K090991COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUOE-Woo Technology2009-10-091850
K090171COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3DE-Woo Technology2009-04-30970
K082410MASTER3DSE-Woo Technology2008-10-31710
K081847PICASSO MASTER, ECT AND MASTER 3DE-Woo Technology2008-08-21520
K070658DENTAL DIGITAL PANORAMIC/3D IMAGING SYSTEME-Woo Technology2007-04-05270

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