FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ECHELON Oval V 5.1 MRI System
K Number: K153547
·
Decision Mar 31, 2016
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
1098
Applicant Total
100
Review Days
111
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ECHELON Oval V 5.1 MRI System
- K Number
- K153547
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hitachi Medical Systems America, Inc.
- Date Received
- December 11, 2015
- Decision Date
- March 31, 2016
- 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
APERTO Lucent MRI System
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
Other Clearances by Hitachi Medical Systems America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K163528 | HITACHI Supria Whole-body X-ray CT System Phase 3 | Mar 3, 2017 | Substantially Equivalent |
| K162079 | TRILLIUM Oval Head Coil 32 | Sep 16, 2016 | Substantially Equivalent |
| K161748 | SUPRIA w/guideShot Option | Aug 17, 2016 | Substantially Equivalent |
| K160152 | Trillium Oval V 5.1 MRI System | May 20, 2016 | Substantially Equivalent |
| K150595 | SCENARIA Phase 3 Whole-body X-ray CT System | Oct 30, 2015 | Substantially Equivalent |
| K150565 | Supria Whole-body X-ray CT System | Sep 30, 2015 | Substantially Equivalent |
| K151015 | ECHELON Oval V 5.0 MRI System | Jul 29, 2015 | Substantially Equivalent |
| K143537 | Sirius Starmobile tiara | Mar 6, 2015 | Substantially Equivalent |
| K142734 | TRILLIUM Oval MR System | Mar 2, 2015 | Substantially Equivalent |
| K123509 | SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM | Mar 29, 2013 | Substantially Equivalent |