Swoop® Portable MR Imaging® System
Hyperfine, Inc. · Radiology
Open FDA's page for this record- Third party flag
- N
- City
- Guilforf
- Advisory committee description
- Radiology
- Address 1
- 351 New Whitfield St.
- Statement or summary
- Summary
- Product code
- LNH
- Zip code
- 06437
- Applicant
- Hyperfine, Inc.
- Decision date
- 2026-08-19
- Decision code
- SESE
- Country code
- US
- Device name
- Swoop® Portable MR Imaging® System
- Advisory committee
- RA
- Contact
- Jon Wojculewicz
- K number
- K262622
- State
- CT
- Date received
- 2026-07-28
- Review advisory committee
- RA
- Postal code
- 06437
- Decision description
- Substantially Equivalent
- Clearance type
- Special
- Harmonized identifiers (openFDA)
- Device name
- System, Nuclear Magnetic Resonance Imaging
- Medical specialty description
- Radiology
- Regulation number
- 892.1000
- Device class
- 2
- Registration number
- 2029299, 1723170, 3008632256, 2432211, 1221108, 3006262888, 3023003446, 3006738448, 3015223550, 3033527281, 3006849754, 3009882464, 3004531751, 9616047, 3017383732, 3016727312, 9617277, 3027339477, 3019595609, 3014232555, 3013679558, 3005517190, 3015425142, 3023385454, 3013695852, 3027325776, 3012761544, 9611343, 3009755250, 2520313, 3002808157, 3013343065, 1650907, 3021593788, 3008355361, 3010398867, 3004526608, 3012439308, 3031503890, 3004977335 +108 more
- FEI number
- 1000143606, 3008632256, 2432211, 1221108, 3006262888, 3023003446, 3006738448, 3015223550, 3033527281, 3006849754, 3009882464, 3002807880, 3004531751, 3017383732, 3016727312, 3027339477, 3019595609, 3014232555, 3013679558, 3003190524, 3005517190, 3015425142, 3023385454, 3013695852, 3002806926, 3027325776, 3012761544, 2520313, 3009755250, 3002808157, 3013343065, 3021593788, 3008355361, 3010398867, 3004526608, 3012439308, 3031503890, 3004977335, 3036666444, 3008447096 +108 more