Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Swoop Portable MR Imaging System

K-Number: K223247 · 2022-12-06

ApplicantHyperfine, Inc.
Decision Date2022-12-06
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 2022-12-06 under approval number K223247. 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 2022-12-06. It is manufactured by Hyperfine, Inc.. The 510(k) number is K223247.

When was Swoop Portable MR Imaging System approved by the FDA?

Swoop Portable MR Imaging System received FDA 510(k) clearance on 2022-12-06, under approval number K223247.

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.

K212456Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System K211818Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System K223268BrainInsight K221923Swoop Portable MR Imaging System K220815BrainInsight K221393Swoop Portable MR Imaging System

View all 13 devices →

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.

↑