Hyperfine, Inc

FDA Device Registration & Listing · Guilford, CT, US · Registration 3014310698

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014310698
FEI Number
3014310698
Entity Name
Hyperfine, Inc
City/State/Country
Guilford, CT, US
Establishment Address
351 New Whitfield Street, Guilford, CT 06437, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Hyperfine, Inc. (Owner Number: 10077154)
Owner / Operator Contact Address
351 New Whitfield St, Guilford, CT 06437, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K253489
PMA Number
N/A

All Registered Proprietary Names

BrainInsight Back Cushion Swoop Portable MR Imaging System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2023-02-14
KXH Cradle, Patient, Radiologic Radiology Class 1 892.1830 2023-08-02
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-14
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2026-04-14

Official Correspondent

Robert Fasciano

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Hyperfine, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K242270 Orthofix Srl OrthoNext Platform System 2024-12-19
K261713 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.6.0) 2026-06-18
K243647 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.5) 2025-06-30
K033504 General Electric Co. GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM 2003-11-25
K013636 GE Medical Systems SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY 2002-01-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0029-2007 Hitachi Medical Systems America Inc 2
MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J.
Z-0033-2014 Philips Medical Systems (Cleveland) Inc 2
Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.
Z-0389-2024 Philips North America Llc 2
Achieva 1.5T
Z-0390-2024 Philips North America Llc 2
Achieva 1.5T Conversion
Z-0391-2024 Philips North America Llc 2
Achieva 1.5T Initial System

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014310698. Last updated year: 2026. Please use registration number 3014310698 when referencing this establishment in official correspondence.
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