Swoop Portable MR Imaging System

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref 900-11001-06 Model 850-11001-06 (900-11001-06, in crate)

by Hyperfine, Inc.

Identity

Trade Name: Swoop® Portable MR Imaging® System EUDAMED
Swoop Portable MRI Scanner FDA UDI
Generic Name: Extremity MRI system, permanent magnet FDA UDI
Device Name: Swoop® Portable MR Imaging® System EUDAMED
Swoop Portable MRI Scanner (Mk1.9) FDA UDI
Model / Reference: 850-11001-06 (900-11001-06, in crate) EUDAMED
900-11001-06 EUDAMED
850-11001-06 FDA UDI
Description: Swoop Portable MRI Scanner (Mk1.9) FDA UDI

Identifiers

Primary DI / UDI-DI: 00850043319009 EUDAMEDFDA UDI
Basic UDI-DI: 0860000606100001R3 EUDAMED
510(k) Number: K221923 FDA UDI
FDA Product Code: LNH FDA UDI
EMDN Code: Z11050104 CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T EUDAMED
GMDN Term: Extremity MRI system, permanent magnet FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 892.1000 FDA UDI
Market of Registration: Italy EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

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

Yes

FDA UDI

Category: Full-body MRI system, superconducting magnet

The Swoop Portable MR Imaging System is a Class IIa magnetic resonance imaging device designed for brain imaging. It is an ultra-low-field MRI system intended for point-of-care use.

The system is non-sterile, non-implantable, and not reusable. It is supplied as a single unit with model number 850-11001-06 (reference 900-11001-06 in crate) and is authorized under FDA 510(k) and MDR regulations. It is suitable for use in settings such as intensive care units and does not contain latex, animal tissues, or medicinal products.

Similar devices

Also classified as Full-body MRI system, superconducting magnet.

iTX Extremity 18 Flare Coil set 1.5T — Siemens Shenzhen Magnetic Resonance Ltd. · Class II
MAGNETOM Sola Fit — Siemens Healthcare · Class II
8 channel wrist coil — Siemens Shenzhen Magnetic Resonance Ltd. · Class II
Head/Neck 64 CS Coil 3T — Siemens Healthcare · Class II
1.5T HDxt Upgrade Kit — GE MEDICAL SYSTEMS, INC. · Class IIa
Flex Large 8 Coil Set 1.5T — Siemens Shenzhen Magnetic Resonance Ltd. · Class II
Flex small 4 MR coil set 3T — Siemens Healthcare · Class II
InVision 1.5 Surgical Theatre — IMRIS Imaging, Inc. · Class II

Frequently asked questions

What is the Swoop Portable MR Imaging System used for?

The Swoop Portable MR Imaging System is designed for brain imaging and intended for point-of-care use, particularly in settings such as intensive care units, as it is an ultra-low-field magnetic resonance imaging device.

Is the Swoop Portable MR Imaging System sterile or reusable?

The system is non-sterile and not reusable; it is supplied as a single unit for one-time use only, with no reprocessing or sterilization indicated.

What model and reference numbers identify the Swoop Portable MR Imaging System?

The device is supplied as model number 850-11001-06, with reference number 900-11001-06 when packaged in a crate, which distinguishes it from other similar systems.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Hyperfine, Inc. and the Swoop® Portable MR Imaging® System, Hyperfine Swoop® Portable MR Brain Imaging System Meets New Standards ..., The Swoop® Portable MR Imaging® System - hyperfinemri.com, Hyperfine's Swoop Portable MRI System, USA - Medical Device Network

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K253489	Class IIa	Active
FDA 510(k)	United States	FDA_510K	K240944	Class IIa	Active
FDA 510(k)	United States	FDA_510K	K251276	Class IIa	Active
EUDAMED	European Union	CE/MDR	0860000606100001R3	Class IIa	Active

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Manufacturer

Manufacturer: Hyperfine, Inc.
EUDAMED SRN: US-MF-000029806
Authorised Representative: Emergo Europe B.V. NL-AR-000000116

Sources (3)

EUDAMED 1acfd84e-c787-4cf4-a887-8ef6eb8c8b19 61 fields · synced Oct 1, 2026
FDA UDI 23e46fa6-5521-4192-8c87-a75060f88a7a 34 fields · synced May 30, 2026
FDA 510(k) K253489 1 fields · synced May 18, 2026