FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Swoop® Portable MR Imaging® System (V2)
K Number: K250236
·
Decision May 30, 2025
Classifications
1
FEI Numbers
152
Registration Numbers
152
Same Product Code
1071
Applicant Total
12
Review Days
123
Basic Information
- Device Name
- Swoop® Portable MR Imaging® System (V2)
- K Number
- K250236
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hyperfine, Inc.
- Date Received
- January 27, 2025
- Decision Date
- May 30, 2025
- Product Code
- LNH
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | FDA class 2 | Radiology |
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Other Clearances by Hyperfine, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251276 | Swoop® Portable MR Imaging® System | May 21, 2025 | Substantially Equivalent |
| K240944 | Swoop® Portable MR Imaging® System | Jul 16, 2024 | Substantially Equivalent |
| K232760 | Swoop® Portable MR Imaging System® | Oct 6, 2023 | Substantially Equivalent |
| K230208 | Swoop® Portable MR Imaging System | Feb 22, 2023 | Substantially Equivalent |
| K223268 | BrainInsight | Dec 16, 2022 | Substantially Equivalent |
| K223247 | Swoop Portable MR Imaging System | Dec 6, 2022 | Substantially Equivalent |
| K221923 | Swoop Portable MR Imaging System | Jul 28, 2022 | Substantially Equivalent |
| K220815 | BrainInsight | Jul 19, 2022 | Substantially Equivalent |
| K221393 | Swoop Portable MR Imaging System | Jun 10, 2022 | Substantially Equivalent |
| K212456 | Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System | Nov 17, 2021 | Substantially Equivalent |