GEM OPTION FOR 1.5 MRI SYSTEMS
FDA 510(k) clearance K103335 · decided 2011-03-07
Clearance details
- K-number
- K103335
- Device name
- GEM OPTION FOR 1.5 MRI SYSTEMS
- Applicant
- GE Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2010-11-15
- Decision date
- 2011-03-07
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- MOS
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Aurora, 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.
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 Healthcare, Optima MR450W with GEM. Product Usage - The GEM Option for 1 .5T MRI system recall (Z-1492-2012) | GE Healthcare, LLC | 2012-05-04 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Senographe Pristina 3D (P130020/S005) | GE Healthcare | 2025-11-21 |
| Invenia ABUS Premium, Invenia ABUS Prime (P110006/S011) | GE Healthcare | 2025-02-04 |
| Senographe Pristina 3D and SenoClaire (P130020/S004) | GE Healthcare | 2021-03-23 |
| Invenia ABUS (Automated Breast Ultrasound System) 2.0 (P110006/S010) | GE Healthcare | 2018-08-24 |
| Invenia ABUS 2.0 Automated Breast Ultrasound System (P110006/S009) | GE Healthcare | 2018-05-11 |
| Senographe Pristina 3D (P130020/S003) | GE Healthcare | 2017-12-28 |
| Invenia ABUS Autoated Breast Ultrasound System (P110006/S008) | GE Healthcare | 2017-09-07 |
| Invenia ABUS - Automated Breast Ultrasound System (P110006/S007) | GE Healthcare | 2017-05-01 |