System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
The Automated Scanning Microscope and Image Analysis System for Fluorescence In Situ Hybridization (FISH) Assays is a device used to automate the scanning and interpretation of FISH-stained microscopy slides, supporting cytogenetic and molecular diagnostic testing. It is an FDA Class 2 device regulated under 21 CFR 866.4700 in the Immunology specialty, reviewed by the Pathology panel, with product code NTH, requiring 510(k) clearance. No detailed definition text is provided in the classification record beyond the device name. It is not an implant and does not provide life-sustaining support.
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Basic Information
- Product Code
- NTH
- Device Class
- FDA class 2
- Regulation Number
- 866.4700
- Medical Specialty
- Immunology
- Review Panel
- PA
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K130775 | DUET SYSTEM | May 09, 2014 | Substantially Equivalent | Bioview , Ltd. |
| K122554 | GENASIS SCANVIEW SYSTEM | Feb 07, 2013 | Substantially Equivalent | Applied Spectral Imaging , Ltd. |
| K110345 | SCANVIEW SYSTEM | Oct 19, 2011 | Substantially Equivalent | Applied Spectral Imaging |
| K101291 | SCANVIEW HER2/NEU FISH SYSTEM | Nov 23, 2010 | Substantially Equivalent | Applied Spectral Imaging , Ltd. |
| K080909 | ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000 | Oct 17, 2008 | Substantially Equivalent | Ikonisys, Inc. |
| K043519 | ARIOL HER-2/NEU FISH | Apr 25, 2005 | Substantially Equivalent | Applied Imaging Corp. |
| K042542 | CYTOVISION FOR CEP XY | Jan 10, 2005 | Substantially Equivalent | Applied Imaging Corp. |
| DEN040010 | VYSIS AUTOVYSION SYSTEM | Dec 13, 2004 | Unknown | Vysis |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.