Definition: The Ihc Her2 Manual Read Of A Digital Slide Application Is Intended For Use As An Aid To The Pathologist In The Detection And Semi-quantitative Measurement Of Her2/neu (c-erbb-2) In Formalin-fixed, Paraffin-embedded Normal And Neoplastic Tissue Immun
| Device Type ID | 4905 |
| Device Name | Automated Digital Image Manual Interpretation Microscope |
| Physical State | Automated Digital Microscope Slide Scanner, Computer, Color Monitor, Keyboard And Digital Pathology Information Management Software |
| Technical Method | Digital Microscopy Image Of Stained Tissue On A Microscope Slide, Used To Determine HER2 IHC Status |
| Target Area | Immunohistochemical Stained Microscope Slides |
| Regulation Description | Immunohistochemistry Reagents And Kits. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.1860 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OEO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4905 |
| Device | Automated Digital Image Manual Interpretation Microscope |
| Product Code | OEO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Immunohistochemistry Reagents And Kits. |
| CFR Regulation Number | 864.1860 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
GE HEALTHCARE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS OPERATIONS INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
Ventana Medical Systems Inc | ||
SUBSTANTIALLY EQUIVALENT | 1 | |