Class Class II

Swoop® Portable MR Imaging® System (K253489)

K253489 2025-12-12 Special
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Description

Swoop® Portable MR Imaging® System by Hyperfine, Inc., an FDA 510(k) cleared radiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK253489
Clearance Date2025-12-12
Clearance TypeSpecial
Product CodeLNH
Regulation Number892.1000

Categories

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