# K221393: Swoop Portable MR Imaging System

- Pathway: 510(k) (Special)
- Applicant: Hyperfine, Inc.
- Decided: Jun 10, 2022 after 28 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: 1 generation back to K212456 (2021). 1 ancestor in all.
9 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212456: Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System, Hyperfine, Inc. (2021) Summary page 4.

## Most influential descendants
- K221923: Swoop Portable MR Imaging System (2022), 8 descendants of its own
- 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

## Indications for use
The Swoop® Portable MR Imaging System 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/K221393
Methodology: https://510kreport.com/methodology