# Women'S Imaging Solutions Enterprises, LLC

- Location (FDA's records): Cresskill, NJ
- FDA decisions: 1 (2015–2015): 1 510(k) clearance
- Product codes: IZH (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Biolucent, Inc.: 1 (https://510kreport.com/company/biolucent)

## Recent decisions
- K152038: MammoGRIP (Dec 22, 2015)

Source page: https://510kreport.com/company/women-s-imaging-solutions-enterprises