Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri
The Neurological Stereotaxic Instrument, Real-Time Intraoperative MRI (product code ORR) is a neurosurgical tool used to aid surgeons in planning and conducting general stereotactic neurosurgery within an MRI suite. It provides real-time image guidance during neurosurgical procedures, enabling precise targeting of intracranial structures. As an FDA Class 2 device under regulation 882.4560, it requires 510(k) premarket clearance and falls within the Neurology specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- ORR
- Device Class
- FDA class 2
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
Definition
To aid the surgeon in planning and conducting general stereotactic neurosurgery in an MRI suite.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K181195 | ClearPoint System | Nov 02, 2018 | Substantially Equivalent | Mri Interventions, Inc. |
| K171257 | ClearPoint System | Oct 20, 2017 | Substantially Equivalent | Mri Interventions, Inc. |
| K111073 | SURGIVISION INC. CLEARPOINT SYSTEM | Jun 22, 2011 | Substantially Equivalent | Surgi-Vision, Inc. |
| K100836 | CLEARPOINT SYSTEM | Jun 16, 2010 | Substantially Equivalent | Surgivision, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.