AccessGUDID - DEVICE: Swoop Point-of-Care Magnetic Resonance Imaging Scanner (00860000606141)

GUDID

Device Identifier (DI) Information

Brand Name: Swoop Point-of-Care Magnetic Resonance Imaging Scanner
Version or Model: V1.7 (850-11001-04)
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Hyperfine Operations, Inc.

Primary DI Number: 00860000606141
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 051795046 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37651	Extremity MRI system, permanent magnet	A diagnostic magnetic resonance imaging (MRI) system employing permanent magnet technology specifically designed to image only the head and neck or limbs. Extremity imaging systems are typically closed bore designs with cylindrical or rectangular bore openings but can be "open" bore designs. They include MRI systems with conventional extremity imaging capabilities, conventional systems capable of performing spectroscopy or other real-time imaging procedures necessary for interventional and therapeutic MRI applications, and dedicated MR spectroscopy systems.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LNH	System, Nuclear Magnetic Resonance Imaging

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K201722	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Handling Environment Humidity: between 15 and 85 Percent (%) Relative Humidity
Storage Environment Humidity: between 15 and 85 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 63578c51-9cdf-43ca-a8b3-b8294ab14219
Public Version Date: March 13, 2025
Public Version Number: 2
DI Record Publish Date: September 16, 2020