Swoop Point-of-Care Magnetic Resonance Imaging Scanner

Primary DI
00860000606141
Brand
Swoop Point-of-Care Magnetic Resonance Imaging Scanner
Company
Hyperfine Operations, Inc.
Model
V1.7 (850-11001-04)
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.
Published
2020-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LNHSystem, Nuclear Magnetic Resonance Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201722000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201722000Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner SystemHyperfine Research, Inc.2020-08-11LNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860000606141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860000606141008600006061418600006061410860000606141

GMDN Terms#

Term, Definition table
TermDefinition
Extremity MRI system, permanent magnetA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
775-476-2674support@hyperfine.io

Regulatory Flags#

DUNS number
051795046
Device count
1
Serial number
true

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Primary DI, Brand, Model table
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00850043319153Hyperfine Foam Back PadV2204-00081-012026-05-26
00850043319146Head Stabilizer900-11022-002024-12-11
00850043319160Swoop Portable MR Imaging Scannerv2.2900-11050-022025-12-04
00850043319184Swoop Transmit and Receive Radio Frequency Head Coilv2.2900-11015-012025-12-04
00850043319047Hyperfine Foam Head Pad810-11108-002023-01-25
00850043319023Swoop Transmit and Receive Radio Frequency Head Coil900-11011-062023-02-16
00850043319009Swoop Portable MRI Scanner850-11001-062023-02-15
00860000606165Swoop Transmit and Receive Radio Frequency Head Coil850-11016-052021-07-26
00860000606172Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner850-11001-052021-07-26
00860000606189BrainInsightVersion 1.02021-03-05
00860000606134Swoop Site Quality Assurance PhantomV1.0 (810-11049-01)2020-09-16
00860000606158Swoop Transmit and Receive Radio Frequency Head CoilV2.0 (815-11016-04)2020-09-16

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