← FDA Medical Device Classifications
Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri
ORR · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.4560
Classification
- FDA Product Code
ORR- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 882.4560
- Review panel
- NE
- Medical specialty
- Neurology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
To aid the surgeon in planning and conducting general stereotactic neurosurgery in an MRI suite.
Market data
- Cleared 510(k) submissions
- 4
- Registered establishments
- 2
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown