# Ikonisys, Inc.

- Location (FDA's records): New Haven, CT
- FDA decisions: 4 (2006–2008): 4 510(k) clearances
- Product codes: JOY (3), NTH (1)
- Predicates its devices cite: 9 (3 its own); citations of its devices by later devices: 3 (3 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
- Bioview, Ltd.: 5 (https://510kreport.com/company/bioview)
- Vysis: 1 (https://510kreport.com/company/vysis)

## Its most-cited devices
- K052577: Ikoniscope Fastfish Amnio Imaging System (2006), cited by 2
- K061392: Ikoniscope Fastfish Auto/Amniocyte Test System (2006), cited by 1

## Recent decisions
- K080909: Iconoscope Oncofish HER2 Test System, Model 2000 (Oct 17, 2008)
- K062755: Ikoniscope Oncofish Bladder Test System (Jan 4, 2007)
- K061392: Ikoniscope Fastfish Auto/Amniocyte Test System (Aug 1, 2006)
- K052577: Ikoniscope Fastfish Amnio Imaging System (Jan 24, 2006)

Source page: https://510kreport.com/company/ikonisys