Swoop® Portable MR Imaging® System
FDA 510(k) K262622 · Hyperfine, Inc.
510(k) numberK262622
Submission
- Device name
- Swoop® Portable MR Imaging® System
- Applicant
- Hyperfine, Inc.
Guilforf, CT, US - Received
- July 28, 2026
- Decision date
- August 19, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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More from Nordicneurolab AS
| 510(k) | Device | Decision |
|---|---|---|
| K253489 | Swoop® Portable MR Imaging® SystemLNH · Special | 12/12/2025SE |
| K250236 | Swoop® Portable MR Imaging® System (V2)LNH · Traditional | 05/30/2025SE |
| K251276 | Swoop® Portable MR Imaging® SystemLNH · Special | 05/21/2025SE |
| K240944 | Swoop® Portable MR Imaging® SystemLNH · Special | 07/16/2024SE |
| K232760 | Swoop® Portable MR Imaging System®LNH · Special | 10/06/2023SE |
| K230208 | Swoop® Portable MR Imaging SystemLNH · Special | 02/22/2023SE |
| K223268 | BrainInsightQIH · Traditional | 12/16/2022SE |
| K223247 | Swoop Portable MR Imaging SystemLNH · Special | 12/06/2022SE |
| K221923 | Swoop Portable MR Imaging SystemLNH · Special | 07/28/2022SE |
| K220815 | BrainInsightQIH · Traditional | 07/19/2022SE |
Questions and answers
When was Swoop® Portable MR Imaging® System cleared by the FDA?
Swoop® Portable MR Imaging® System (K262622) received a 510(k) decision of Substantially Equivalent on August 19, 2026, 22 days after the submission was received.
What is the product code of K262622?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.