Swoop Transmit and Receive Radio Frequency Head Coil

GUDID 00860000606158

The Transmit and Receive Radio Frequency Head Coil, like RF coils used on conventional high-field systems (e.g. 1.5T, 3T), is used to transmit RF pulses and to receive MR signals. It consists of one linear mode transmit coil, and an 8-channel receive phased array.

HYPERFINE RESEARCH, INC.

MRI system coil, radio-frequency

Primary Device ID	00860000606158
NIH Device Record Key	7fd2e3b1-4b22-4123-b903-19404c698cf9
Commercial Distribution Status	In Commercial Distribution
Brand Name	Swoop Transmit and Receive Radio Frequency Head Coil
Version Model Number	V2.0 (815-11016-04)
Company DUNS	051795046
Company Name	HYPERFINE RESEARCH, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	775-476-2674
Email	support@hyperfine.io
Phone	775-476-2674
Email	support@hyperfine.io
Phone	775-476-2674
Email	support@hyperfine.io
Phone	775-476-2674
Email	support@hyperfine.io
Phone	775-476-2674
Email	support@hyperfine.io
Phone	775-476-2674
Email	support@hyperfine.io
Phone	775-476-2674
Email	support@hyperfine.io
Phone	775-476-2674
Email	support@hyperfine.io
Phone	775-476-2674
Email	support@hyperfine.io
Phone	775-476-2674
Email	support@hyperfine.io
Phone	775-476-2674
Email	support@hyperfine.io
Phone	775-476-2674
Email	support@hyperfine.io
Phone	775-476-2674
Email	support@hyperfine.io
Phone	775-476-2674
Email	support@hyperfine.io

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000606158 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K201722

FDA Product Code

MOS	Coil, Magnetic Resonance, Specialty

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-09-24
Device Publish Date	2020-09-16

On-Brand Devices [Swoop Transmit and Receive Radio Frequency Head Coil]

00860000606158	The Transmit and Receive Radio Frequency Head Coil, like RF coils used on conventional high-fiel
00860000606165	Transmit and Receive Radio Frequency (RF) Head Coil for Use with the Swoop POC MRI Scanner (Mk1.
00850043319023	Transmit and Receive Radio Frequency (RF) Head Coil for Use with the Swoop POC MRI Scanner (Mk1.