FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OASIS MRI System
K Number: K211406
·
Decision Oct 7, 2021
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
1098
Applicant Total
12
Review Days
154
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Basic Information
- Device Name
- OASIS MRI System
- K Number
- K211406
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hitachi Healthcare Americas
- Date Received
- May 6, 2021
- Decision Date
- October 7, 2021
- 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 Hitachi Healthcare Americas
| K Number | Device Name | ||
|---|---|---|---|
| K202422 | Arietta 65 | Nov 4, 2020 | Substantially Equivalent |
| K202030 | OASIS MRI System | Oct 21, 2020 | Substantially Equivalent |
| K200498 | SCENARIA View | Jul 17, 2020 | Substantially Equivalent |
| K192851 | OASIS MRI System | Feb 21, 2020 | Substantially Equivalent |
| K190841 | SCENARIA View | Sep 13, 2019 | Substantially Equivalent |
| K191233 | ARIETTA 750 | Aug 9, 2019 | Substantially Equivalent |
| K190248 | ARIETTA 50 | Apr 2, 2019 | Substantially Equivalent |
| K183291 | Supria True64 Whole-Body X-Ray CT System | Feb 1, 2019 | Substantially Equivalent |
| K183456 | Aloka Arietta 850 | Jan 28, 2019 | Substantially Equivalent |
| K172492 | Optical Topography System ETG-4100 | Aug 17, 2018 | Substantially Equivalent |