# K251276: Swoop® Portable MR Imaging® System

- Pathway: 510(k) (Special)
- Applicant: Hyperfine, Inc.
- Decided: May 21, 2025 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: 12 generations back to K001773 (2000). 14 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240944: Swoop® Portable MR Imaging® System, Hyperfine, Inc. (2024) Summary page 5.

## Most influential descendants
- K253489: Swoop® Portable MR Imaging® System (2025), 1 descendant of its own
- K262622: Swoop® Portable MR Imaging® System (2026), 0 descendants of its own

## Indications for use
The Swoop Portable MR Imaging System is a portable, ultra-low field 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/K251276
Methodology: https://510kreport.com/methodology