Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Lightlab Imaging, Inc. · Predicate Candidate Screening

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

92 daysmedian FDA review time
135 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K160878OPTIS Metallic Stent Optimization E.4 SWLightlab Imaging, Inc.2016-06-29910
K152120OPTIS Mobile SystemLightlab Imaging, Inc.2015-10-29910
K151286OPTIS Integrated System Mobile WorkstationLightlab Imaging, Inc.2015-08-05830
K150878ILUMIEN OPTISLightlab Imaging, Inc.2015-07-151050
K150237ILUMIEN, Drageonfly OPTIS Imaging CatheterLightlab Imaging, Inc.2015-05-05920
K141453ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETERLightlab Imaging, Inc.2014-09-191090
K141769OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETERLightlab Imaging, Inc.2014-08-18480
K123369ILUMIEN OPTISLightlab Imaging, Inc.2013-01-30900
K111201C7 XR IMAGING SYSTEMLightlab Imaging, Inc.2011-08-101030
K093857C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND Lightlab Imaging, Inc.2010-04-301350

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