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Index/Hyperfine, Inc.
ALT-006774K221393Green Status

Swoop Portable MR Imaging System

Hyperfine, Inc. · Manufacturer

All identifiers (8)
Aletia (canonical)ALT-006774
FDA 510(k) · US (primary)K221393
FDA 510(k) · USK223247
FDA 510(k) · USK240944
FDA 510(k) · USK253489
FDA 510(k) · USK251276
FDA 510(k) · USK232760
FDA 510(k) · USK221923

Overview

Accountability Tier
Tier 2

Regulatory Registrations

🌐
US
FDA
ID: K221393
510k

Lifecycle Signals

Last Automated Sync
Jun 2026
Last Clinical Review
Not reviewed
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