# K221923: Swoop Portable MR Imaging System

- Pathway: 510(k) (Special)
- Applicant: Hyperfine, Inc.
- Decided: Jul 28, 2022 after 27 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K001773 (2000). 9 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201722: Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System, Hyperfine Research, Inc. (2020) Summary page 4.
- K221393: Swoop Portable MR Imaging System, Hyperfine, Inc. (2022) Summary page 4.

## Most influential descendants
- K223247: Swoop Portable MR Imaging System (2022), 7 descendants of its own
- K230208: Swoop® Portable MR Imaging System™ (2023), 6 descendants of its own
- K232760: Swoop® Portable MR Imaging System® (2023), 5 descendants of its own
- K240944: Swoop® Portable MR Imaging® System (2024), 4 descendants of its own
- K250236: Swoop® Portable MR Imaging® System (V2) (2025), 2 descendants of its own

## Indications for use
Hyperfine Swoop® Portable MR Imaging System(TM) is a bedside magnetic resonance imaging device for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

Source page: https://510kreport.com/device/K221923
Methodology: https://510kreport.com/methodology