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Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner

FDA UDI

Class II (US FDA UDI)

by Hyperfine Operations, Inc.

Identity

Trade Name
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner FDA UDI
Generic Name
Extremity MRI system, permanent magnet FDA UDI
Device Name
Swoop POC MRI Scanner (Mk1.8 version) FDA UDI
Model / Reference
850-11001-05 FDA UDI
Description
Swoop POC MRI Scanner (Mk1.8 version) FDA UDI

Identifiers

Primary DI / UDI-DI
00860000606172 FDA UDI
510(k) Number
K201722 FDA UDI
K211818 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Extremity MRI system, permanent magnet

Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner by Hyperfine Operations, Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Extremity MRI system, permanent magnet.

Cleared under the same submission

K201722 also covers:

K211818 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hyperfine Operations, Inc.

Sources (1)

  • FDA UDI 768d698d-a98a-4bc1-b122-7152ec3d95d3 35 fields · synced Jun 6, 2026