OASIS MRI SYSTEM
FDA 510(k) clearance K093044 · decided 2010-03-16
Clearance details
- K-number
- K093044
- Device name
- OASIS MRI SYSTEM
- Applicant
- Hitachi Medical Systems America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-09-30
- Decision date
- 2010-03-16
- Days to decision
- 167 days
- Clearance type
- Traditional
- Product code
- LNI
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Twinsburg, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ECHELON SPECTROSCOPY PACKAGE (K071506) | Hitachi Medical Systems America, Inc. | 2007-06-28 |
| PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI (K011604) | Ge Medical Systems, Inc. | 2001-08-22 |
| EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3 (K010129) | Toshiba America Medical Systems, In.C | 2001-04-05 |
| MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM (K003575) | GE Medical Systems | 2001-01-17 |
| MR SPECTROSCOPY PACKAGE (K991568) | Philips Medical Systems (Cleveland), Inc. | 1999-07-19 |
| SAGE 7 (K984167) | GE Medical Systems | 1999-01-12 |
| CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM (K962627) | Siemens Medical Solutions USA, Inc. | 1997-04-03 |
| GYREX 2T-PRESTIGE (K970005) | Elscint, Inc. | 1997-03-28 |
| HYDROGEN SPECTROSCOPY OPTION-PROBE #M1040HS/HT (K930265) | GE Medical Systems | 1995-04-25 |
Recalls involving this device
No recalls on record reference this clearance.