Swoop Point-of-Care Magnetic Resonance Imaging Scanner

FDA UDI

Class II (US FDA UDI)

by Hyperfine Operations, Inc.

Identity

Trade Name: Swoop Point-of-Care Magnetic Resonance Imaging Scanner FDA UDI
Generic Name: Extremity MRI system, permanent magnet FDA UDI
Device Name: The Point-Of-Care Magnetic Resonance Imaging (POC MRI) system is an MRI device that is portable allowing patient bedside imaging. It enables visualization of the internal structures of the head using standard magnetic resonance imaging contrasts. The main interface is a commercial off-the-shelf device, used to operate the system, provide access to patient data, exam set-up, exam execution, and MRI image data viewing for quality control purposes as well as for cloud storage interactions. The POC MRI system can generate MRI data sets with a broad range of contrasts. The user interface includes touch screen menus, controls, indicators and navigation icons that allow the operator to control the system and to view imagery. FDA UDI
Model / Reference: V1.7 (850-11001-04) FDA UDI
Description: The Point-Of-Care Magnetic Resonance Imaging (POC MRI) system is an MRI device that is portable allowing patient bedside imaging. It enables visualization of the internal structures of the head using standard magnetic resonance imaging contrasts. The main interface is a commercial off-the-shelf device, used to operate the system, provide access to patient data, exam set-up, exam execution, and MRI image data viewing for quality control purposes as well as for cloud storage interactions. The POC MRI system can generate MRI data sets with a broad range of contrasts. The user interface includes touch screen menus, controls, indicators and navigation icons that allow the operator to control the system and to view imagery. FDA UDI

Identifiers

Primary DI / UDI-DI: 00860000606141 FDA UDI
510(k) Number: K201722 FDA UDI
FDA Product Code: LNH FDA UDI
GMDN Term: Extremity MRI system, permanent magnet FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1000 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Extremity MRI system, permanent magnet

Swoop Point-of-Care Magnetic Resonance Imaging Scanner by Hyperfine Operations, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Extremity MRI system, permanent magnet.

WristView — Aspect Imaging, Ltd. · Class II
PoleStar®, Trumpf JUPITER™ — MEDTRONIC NAVIGATION, INC. · Class II
S-scan — Esaote · Class II
PoleStar® — MEDTRONIC NAVIGATION, INC. · Class II
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner — Hyperfine Operations, Inc. · Class II

Cleared under the same submission

K201722 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Hyperfine Operations, Inc.

Sources (1)

FDA UDI 63578c51-9cdf-43ca-a8b3-b8294ab14219 36 fields · synced May 30, 2026