XENOVIEW 3.0T Chest Coil— 510(k) K243316
Substantially EquivalentPolarean, Inc.
FDA 510(k) clearance K243316 for XENOVIEW 3.0T Chest Coil, Substantially Equivalent on 2024-11-19. Applicant: Polarean, Inc.. Device class: 2.
Clearance details
- Applicant
- Polarean, Inc.
- Product code
- Code MOS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Durham, NC, US
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More clearances from Polarean, Inc.
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