Swoop® Portable MR Imaging System
K-Number: K230208 · 2023-02-22
ApplicantHyperfine, Inc.
Decision Date2023-02-22
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Swoop® Portable MR Imaging System is a medical device manufactured by Hyperfine, Inc.. It received FDA 510(k) clearance on 2023-02-22 under approval number K230208. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Swoop® Portable MR Imaging System?
Swoop® Portable MR Imaging System is a medical device that received FDA 510(k) clearance on 2023-02-22. It is manufactured by Hyperfine, Inc.. The 510(k) number is K230208.
When was Swoop® Portable MR Imaging System approved by the FDA?
Swoop® Portable MR Imaging System received FDA 510(k) clearance on 2023-02-22, under approval number K230208.
What company makes Swoop® Portable MR Imaging System?
Swoop® Portable MR Imaging System is manufactured by Hyperfine, Inc..
What is the FDA product code for Swoop® Portable MR Imaging System?
The FDA product code for Swoop® Portable MR Imaging System is LNH.
Related Clinical Trials
NCT01143454
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
RECRUITING
NCT03331380
Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System
RECRUITING
NCT04981223
Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging
COMPLETED
NCT07608614
Sleep and Performance
RECRUITING
NCT07399574
Diagnostic Accuracy of A Diquat Quantitative Detection Kit and A Portable Mass Spectrometry System for Quantifying Diquat Concentrations in Human Blood Samples
NOT_YET_RECRUITING
NCT05673408
NIBP Validation Study
RECRUITING
Related PubMed Literature
PMID: 41887630
Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa.
BMJ open (2026)
PMID: 40775988
B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation.
Studies in health technology and informatics (2025)
PMID: 40346298
An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients.
NPJ digital medicine (2025)
Other Devices by Hyperfine, Inc.
Related Devices (Code: LNH)
K162940MultiBand SENSEPhilips Medical Systems Nederland B.V.
K162183Vantage Galan 3T, MRT-3020, V4.0Toshibamedical Systems Corporation
K162102MAGNETOM Avantofit, MAGNETOM SkyrafitSiemens Medi Cal Solutions, Inc.
K162403HyperBandGe Medical Systems, LLC
K161795MAGNETOM ESSENZASiemens Medical Solutions USA, Inc.
K161973G-scan Brio, S-scanEsaote, S.p.A.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.