Swoop® Portable MR Imaging System®
FDA 510(k) K232760 · Hyperfine, Inc.
510(k) numberK232760
Submission
- Device name
- Swoop® Portable MR Imaging System®
- Applicant
- Hyperfine, Inc.
Guilforf, CT, US - Received
- September 8, 2023
- Decision date
- October 6, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K262622 | Swoop® Portable MR Imaging® SystemLNH · Special | Hyperfine, Inc. | 08/19/2026SE |
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More from Canon Medical Systems Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K262622 | Swoop® Portable MR Imaging® SystemLNH · Special | 08/19/2026SE |
| 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 |
| 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® (K232760) received a 510(k) decision of Substantially Equivalent on October 6, 2023, 28 days after the submission was received.
What is the product code of K232760?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.