Swoop Point-of-Care Magnetic Resonance Imaging Scanner

Basic Information

• Brand Name: Swoop Point-of-Care Magnetic Resonance Imaging Scanner
• Primary DI: 00860000606141
• Version / Model: V1.7 (850-11001-04)
• Company Name: HYPERFINE RESEARCH, INC.
• Labeler DUNS: 051795046
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-16
• Public Version: 1
• Public Version Date: 2020-09-24
• Public Version Status: New
• Public Device Record Key: 63578c51-9cdf-43ca-a8b3-b8294ab14219

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

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	892.1000	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860000606141	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K201722	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 15 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 15 – 85 Percent (%) Relative Humidity