NEURO II-SE, MODELS: OR-DR-OR, OR-MB
FDA 510(k) clearance K071099 · decided 2007-05-22
Clearance details
- K-number
- K071099
- Device name
- NEURO II-SE, MODELS: OR-DR-OR, OR-MB
- Applicant
- Imris, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-04-19
- Decision date
- 2007-05-22
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Rockville, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indic recall (Z-1098-2016) | Deerfield Imaging | 2016-03-11 |
| IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used recall (Z-0428-2013) | Innovative Magnetic Resonance Imaging Systems Inc. | 2012-11-21 |