Atlas FDA

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

Ziehm Imaging, Inc. — Predicate Candidate Screening

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

58 daysmedian FDA review time
168 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K092438ZIEHM SOLOZiehm Imaging, Inc.2009-12-231383
K083545ZIEHM VISION RFDZiehm Imaging, Inc.2009-05-151682
K073346ZIEHM VISION 2Ziehm Imaging, Inc.2008-03-211134
K061534ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEMZiehm Imaging, Inc.2006-07-07350
K061310ZIEHM VARIO 3D DIGITAL MOBILE IMAGING SYSTEMZiehm Imaging, Inc.2006-07-07580
K061203ZIEHM VISION R DIGITAL MOBILE IMAGING SYSTEMZiehm Imaging, Inc.2006-06-19493
K051064ZIEHM QUANTUMZiehm Imaging, Inc.2005-05-26300

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