| Device Type ID | 4950 |
| Device Name | Microtome, Rotary |
| Regulation Description | Tissue Processing Equipment. |
| Regulation Medical Specialty | Pathology |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 864.3010 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | IDO |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4950 |
| Device | Microtome, Rotary |
| Product Code | IDO |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Tissue Processing Equipment. |
| CFR Regulation Number | 864.3010 [🔎] |
| Device Problems | |
|---|---|
Human Factors Issue | 6 |
Human-Device Interface Problem | 4 |
Use Of Device Problem | 4 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Insufficient Information | 2 |
Misassembly By Users | 1 |
Device Handling Problem | 1 |
Program Or Algorithm Execution Failure | 1 |
Device Stops Intermittently | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
| Total Device Problems | 24 |