FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
APERTO Lucent MRI System
K Number: K253862
·
Decision Apr 6, 2026
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
1098
Applicant Total
64
Review Days
124
Basic Information
- Device Name
- APERTO Lucent MRI System
- K Number
- K253862
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fujifilm Corporation
- Date Received
- December 3, 2025
- Decision Date
- April 6, 2026
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LNH), ordered by most recent decision date.
uMR Astra
FDA 510(k)
FDA Class 2
·Radiology
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
FDA 510(k)
FDA Class 2
·Radiology
S-scan Open (100001800)
FDA 510(k)
FDA Class 2
·Radiology
nordicAudio (1.0)
FDA 510(k)
FDA Class 2
·Radiology
Embrace Neonatal MRI System
FDA 510(k)
FDA Class 2
·Radiology
LiverMultiScan (v6.0)
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Fujifilm Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K253137 | FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T | Jun 16, 2026 | Substantially Equivalent |
| K254075 | Synapse Lung Nodule AI | May 27, 2026 | Substantially Equivalent |
| K254189 | Synapse 3D Base Tools (V7.2) | Apr 30, 2026 | Substantially Equivalent |
| K251861 | FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000 | Mar 9, 2026 | Substantially Equivalent |
| K250550 | FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit | Feb 17, 2026 | Substantially Equivalent |
| K253568 | Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR | Feb 6, 2026 | Substantially Equivalent |
| K250863 | FUJIFILM Ultrasonic Endoscope EB-710US | Dec 12, 2025 | Substantially Equivalent |
| K251386 | ECHELON Synergy | Sep 17, 2025 | Substantially Equivalent |
| K244017 | FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 | Jun 13, 2025 | Substantially Equivalent |
| K243512 | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP | Jun 10, 2025 | Substantially Equivalent |