DISCOVERY MR750W 3.0T
FDA 510(k) clearance K103327 · decided 2011-09-30
Clearance details
- K-number
- K103327
- Device name
- DISCOVERY MR750W 3.0T
- Applicant
- Ge Healthcare Japan Corporation
- Decision
- Substantially Equivalent
- Date received
- 2010-11-12
- Decision date
- 2011-09-30
- Days to decision
- 322 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Hino-Shi, Tokyo, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with recall (Z-1533-2014) | GE Healthcare, LLC | 2014-05-01 |
| GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discov recall (Z-1480-2014) | GE Healthcare, LLC | 2014-04-21 |
| GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model recall (Z-2266-2013) | GE Healthcare, LLC | 2013-09-23 |
| GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293. Product Usage: It is in recall (Z-1100-2013) | GE Healthcare, LLC | 2013-04-11 |