Atlas FDA

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

Ziehm Imaging GmbH — Predicate Candidate Screening

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

92 daysmedian FDA review time
194 days90th percentile
18clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K243646Ziehm Solo FDZiehm Imaging GmbH2025-03-171110
K243735Ziehm Vision FDZiehm Imaging GmbH2025-03-13990
K243303Ziehm Vision RFD 3DZiehm Imaging GmbH2025-01-21920
K243328Ziehm Vision RFDZiehm Imaging GmbH2025-01-15830
K240099Ziehm Vision RFDZiehm Imaging GmbH2024-02-05241
K240020Ziehm Vision FDZiehm Imaging GmbH2024-01-30281
K234109Ziehm Solo FDZiehm Imaging GmbH2024-01-26301
K231700Ziehm Vision FDZiehm Imaging GmbH2023-12-151860
K231669Ziehm Solo FDZiehm Imaging GmbH2023-12-121870
K231692Ziehm Vision RFDZiehm Imaging GmbH2023-11-201640
K231701Ziehm Vision RFD 3DZiehm Imaging GmbH2023-07-10281
K203428Ziehm Vision RFDZiehm Imaging GmbH2021-03-171170
K202360Ziehm Vision RFD 3DZiehm Imaging GmbH2020-09-16280
K193230Ziehm Vision FDZiehm Imaging GmbH2019-12-20250
K190497Ziehm 8000Ziehm Imaging GmbH2019-11-202650
K161976Ziehm Solo FDZiehm Imaging GmbH2016-10-06800
K142740Ziehm Vision RFD 3DZiehm Imaging GmbH2015-04-061940
K132904ZIEHM VISION RFDZiehm Imaging GmbH2013-12-05800

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