ORR
- Product code
- ORR
- Device name
- Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.4560
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- 510(k) clearances (all years, FDA)
- 4 (all years; only the last 3 years are listed here)
FDA classification definition
To aid the surgeon in planning and conducting general stereotactic neurosurgery in an MRI suite.
Official FDA classification page: ORR
Classification and pathway per current FDA publications. Data from openFDA (CC0).