# Ziehm Imaging GmbH

- Location (FDA's records): Nuremberg, DE
- FDA decisions: 25 (2005–2025): 25 510(k) clearances
- Names in FDA's records: Ziehm Imaging GmbH (18); Ziehm Imaging, Inc. (7)
- Product codes: OWB (21), JAA (2), JAK (2)
- 510(k) review time since 2016: median 88 days, against 148 for FDA's reviews in the same codes and years (11 of 16 faster)
- Predicates its devices cite: 32 (25 its own); citations of its devices by later devices: 32 (25 its own)
- Recalls linked to its devices: 20 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ziehm International, Inc.: 3 (https://510kreport.com/company/ziehm-international)
- Ge Oec Medical Systems, Inc.: 2 (https://510kreport.com/company/ge-oec-medical-systems)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Siemens Corp.: 1 (https://510kreport.com/company/siemens)

## Firms that cite its devices most
- Allengers Medical Systems Limited: 2 (https://510kreport.com/company/allengers-medical-systems)
- Nview Medical: 1 (https://510kreport.com/company/nview-medical)
- Medphoton GmbH: 1 (https://510kreport.com/company/medphoton)
- Orthoscan, Inc.: 1 (https://510kreport.com/company/orthoscan)
- Fujifilm Corporation: 1 (https://510kreport.com/company/fujifilm)
- Pulmera, Inc.: 1 (https://510kreport.com/company/pulmera)

## Its most-cited devices
- K073346: Ziehm Vision 2 (2008), cited by 4
- K132904: Ziehm Vision RFD (2013), cited by 3
- K142740: Ziehm Vision RFD 3D (2015), cited by 3
- K061534: Ziehm Vision FD Digital Mobile Imaging System (2006), cited by 2
- K161976: Ziehm Solo FD (2016), cited by 2
- K243303: Ziehm Vision RFD 3D (2025), cited by 2

## Recent decisions
- K243646: Ziehm Solo FD (Mar 17, 2025)
- K243735: Ziehm Vision FD (Mar 13, 2025)
- K243303: Ziehm Vision RFD 3D (Jan 21, 2025)
- K243328: Ziehm Vision RFD (Jan 15, 2025)
- K240099: Ziehm Vision RFD (Feb 5, 2024)
- K240020: Ziehm Vision FD (Jan 30, 2024)
- K234109: Ziehm Solo FD (Jan 26, 2024)
- K231700: Ziehm Vision FD (Dec 15, 2023)

Source page: https://510kreport.com/company/ziehm-imaging