FDA.reportPublic FDA data

Hyperfine Foam Head Pad

Primary DI
00850043319047
Brand
Hyperfine Foam Head Pad
Company
Hyperfine Operations, Inc.
Model
810-11108-00
Device description
Memory foam cushion used as a support device to aid in the positioning of the patient’s head during an MRI procedure.
Published
2023-01-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IWYHolder, Head, Radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWYHolder, Head, RadiographicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850043319047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850043319047008500433190478500433190470850043319047

GMDN Terms#

Term, Definition table
TermDefinition
Radiological headrestA non-sterile device intended to facilitate adequate positioning and immobilization of the patient's head and neck for reproducible positioning during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. The device is in the form of a frame, cushion, or preformed pad that is intended to directly contact the head, and which may be customizable for single-patient use. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
051795046
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
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
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
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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