Ikonisys, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000031487 FEI 3005566046
- Devices
- 6
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
- Authorised rep.
- Emergo Europe B.V.NL
What Ikonisys, Inc. makes
Ikonisys, Inc. manufactures imaging and diagnostic systems for cytological analysis, including automated fluorescence-based platforms for amniotic fluid and bladder cancer testing. Their portfolio includes systems designed to detect genetic markers, such as HER2, in tissue samples and high-volume screening devices for cellular analysis. These devices are primarily used in prenatal and oncological diagnostics to assist in rapid, objective evaluations of cellular samples.
The company’s products are classified under EU Class A and Class II devices, with regulatory listings in the EU’s eudamed database and FDA’s 510(k) clearance registry. These systems are intended for use in clinical settings where precise cellular analysis is required, adhering to stringent regulatory standards for diagnostic accuracy and safety. The manufacturer operates from the United States.
Catalogue
Ikoniscope Fastfish Amnio Imaging System Ref K052577
Regimes: 510(k) Registry: 510(k)Ikoniscope Oncofish Bladder Test System Ref K062755
Regimes: 510(k) Registry: 510(k)Iconoscope Oncofish HER2 Test System, Model 2000 Ref K080909
Regimes: 510(k) Registry: 510(k)Ikoniscope Fastfish Auto/Amniocyte Test System Ref K061392
Regimes: 510(k) Registry: 510(k)Ikoniscope20 High Volume Ref Ikoniscope 20 160
Regimes: CE IVDR Registry: EUDAMEDIkoniscope20 Low Volume Ref IK20LV
Regimes: CE IVDR Registry: EUDAMED
Company details
- EUDAMED SRN
- US-MF-000031487
- FDA FEI number
- 3005566046
- EUDAMED status
- Active
- EUDAMED registered name
- Ikonisys, Inc.
- Registered address
- 5, Science Park, 06511, New Haven, United States
- Website
- www.ikonisys.com
- [email protected]
- PRRC contact
- Mary Stewart
Frequently asked questions
How many devices does Ikonisys, Inc. have in the registry?
The registry currently lists 6 devices for Ikonisys, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ikonisys, Inc.'s devices?
Among its 6 most recently registered devices, Ikonisys, Inc. has devices listed in EUDAMED (2 devices) and FDA 510(k) (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Ikonisys, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Ikonisys, Inc.'s devices are Class II and IVDR Class A. Each device page shows its own class and authorisation.
What are the newest devices from Ikonisys, Inc. in the registry?
The most recently registered devices listed for Ikonisys, Inc. include IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM, IKONISCOPE ONCOFISH BLADDER TEST SYSTEM, ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000 and IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM.