Definition: Automated Microscopic Immunohistochemistry Image- Analysis System To Measure Nuclear Intensity And Percent Positivity With Operator Intervention.
| Device Type ID | 4903 |
| Device Name | Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity |
| 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 | NQN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4903 |
| Device | Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity |
| Product Code | NQN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Immunohistochemistry Reagents And Kits. |
| CFR Regulation Number | 864.1860 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
APPLIED SPECTRAL IMAGING LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS OPERATIONS INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
Ventana Medical Systems Inc | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Heater | 1 |
Fluid Leak | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
None | 1 |
| Total Device Problems | 4 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Leica Biosystems Richmond Inc. | III | Jun-10-2016 |