FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
GENASIS HIPATH IHC FAMILY
K Number: K140957
·
Decision Jan 15, 2015
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
14
Applicant Total
7
Review Days
276
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Basic Information
- Device Name
- GENASIS HIPATH IHC FAMILY
- K Number
- K140957
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.1860
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Applied Spectral Imaging , Ltd.
- Date Received
- April 14, 2014
- Decision Date
- January 15, 2015
- Product Code
- NQN
- Advisory Committee
- Hematology
- Review Advisory Committee
- PA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NQN | Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity | FDA class 2 | Hematology |
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Other Clearances by Applied Spectral Imaging , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K122554 | GENASIS SCANVIEW SYSTEM | Feb 7, 2013 | Substantially Equivalent |
| K101291 | SCANVIEW HER2/NEU FISH SYSTEM | Nov 23, 2010 | Substantially Equivalent |
| K071398 | SCANVIEW, MODEL SC-300 | Oct 4, 2007 | Substantially Equivalent |
| K050236 | FISHVIEW | Jun 27, 2005 | Substantially Equivalent |
| K012103 | BANDVIEW SYSTEM | Sep 14, 2001 | Substantially Equivalent |
| K973950 | RETINAL CUBE | Dec 12, 1997 | Substantially Equivalent |