FDA.reportPublic FDA data

Swoop Site Quality Assurance Phantom

Primary DI
00860000606134
Brand
Swoop Site Quality Assurance Phantom
Company
Hyperfine Operations, Inc.
Model
V1.0 (810-11049-01)
Device description
The Site Quality Assurance Phantom is specifically designed as a medical device and augments the scanner by allowing weekly quality control checks of the functioning of the scanner in the hospital environment.
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
00860000606134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860000606134008600006061348600006061340860000606134

GMDN Terms#

Term, Definition table
TermDefinition
MRI phantom, test objectA device that consists of a uniform density, or a two or three-dimensional (3-D) pattern of objects, materials or openings of varying dimensions and material densities. It is available in both fixed and variable configurations and is a quality assurance (QA) device used in both subjective and quantitative evaluations of various calibration and performance characteristics of magnetic resonance imaging (MRI) systems or magnetic resonance spectroscopy systems and associated image acquisition, display, and analysis computer programs.

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00860000606141Swoop Point-of-Care Magnetic Resonance Imaging ScannerV1.7 (850-11001-04)2020-09-16
00860000606158Swoop Transmit and Receive Radio Frequency Head CoilV2.0 (815-11016-04)2020-09-16

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Primary DI, Brand, Company table
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08720168162854Mask DSPS®-PROSCVRL set/5MACROMEDICS B.V.LNH2026-04-22
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08720168162878Mask DSPS®-PROSCVR set/5MACROMEDICS B.V.LNH2026-04-22
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