Data / Medical devices / United States / Ikonisys, Inc
Ikonisys, Inc: FDA-registered device maker in New Haven, CT, United States, 4 510(k) clearances
Ikonisys, Inc is registered with the FDA (registration 3005566046) in New Haven, CT, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 17, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005566046
- Address
- 5 Science Park, New Haven, CT, United States, 06511
- Owner or operator
- Ikonisys, Inc (10023706)
- Roles
- Manufacturer
- First device listed
- December 10, 2007
- Registered through
- 2026
- Brand names listed
- IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM, IKONISCOPE ONCOFISH BLADDER TEST SYSTEM, Ikoniscope fastFISH Auto/Amniocyte Test System, Ikoniscope® oncoFISH her2 Test System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Automated Cell-Locating | JOY | 2 | Manufacturer | accessdata.fda.gov |
| Reagents, Specific, Analyte | MVU | 1 | Manufacturer | accessdata.fda.gov |
| System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays | NTH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 17, 2008 | K080909 | ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000 | NTH | Substantially Equivalent | Ikonisys, Inc. | accessdata.fda.gov |
| January 4, 2007 | K062755 | IKONISCOPE ONCOFISH BLADDER TEST SYSTEM | JOY | Substantially Equivalent | Ikonisys, Inc. | accessdata.fda.gov |
| August 1, 2006 | K061392 | IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM | JOY | Substantially Equivalent | Ikonisys, Inc. | accessdata.fda.gov |
| January 24, 2006 | K052577 | IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM | JOY | Substantially Equivalent | Ikonisys, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
- All makers of Device, Automated Cell-Locating
- All makers of Reagents, Specific, Analyte
Updated October 17, 2008. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.