510(k) K110345
- Device
- SCANVIEW SYSTEM
- Applicant
- APPLIED SPECTRAL IMAGING
- 510(k) number
- K110345
- Product code
- NTH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-10-19
- Date received
- 2011-02-04
- Regulation
- 866.4700
- Classification name
- System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays
- Medical specialty
- Immunology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAN LAOR
- Address
- 6 Sireni Haifa IL 10551 10551
FDA Registration Numbers#
- 3003909093
- 3005248192
- 9615060
Source Documents#
Other 510(k) Records For Product Code NTH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K130775 | DUET SYSTEM | Bioview , Ltd. | 2014-05-09 |
| K122554 | GENASIS SCANVIEW SYSTEM | Applied Spectral Imaging , Ltd. | 2013-02-07 |
| K101291 | SCANVIEW HER2/NEU FISH SYSTEM | Applied Spectral Imaging , Ltd. | 2010-11-23 |
| K080909 | ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000 | Ikonisys, Inc. | 2008-10-17 |
| K043519 | ARIOL HER-2/NEU FISH | Applied Imaging Corp. | 2005-04-25 |
| K042542 | CYTOVISION FOR CEP XY | Applied Imaging Corp. | 2005-01-10 |
| DEN040010 | VYSIS AUTOVYSION SYSTEM | Vysis | 2004-12-13 |
Legacy Summary#
summary
FDA Review#
Decision Summary