M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM / COMMANDER X6 SYSTEM
FDA 510(k) clearance K994351 · decided 2000-03-22
Clearance details
- K-number
- K994351
- Device name
- M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM / COMMANDER X6 SYSTEM
- Applicant
- Resonance Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-12-23
- Decision date
- 2000-03-22
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Northridge, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Headset Model Number RTC-2K for use with the Serene Sound Digital MRI Compatible High Fide recall (Z-1823-2008) | Resonance Technology Inc | 2008-09-02 |
| Headset Model Number RTC-551-070 for use with the Serene Sound Digital MRI Compatible High recall (Z-1824-2008) | Resonance Technology Inc | 2008-09-02 |