1.5T INFINITY TWINSPEED MR SYSTEM
FDA 510(k) clearance K012200 · decided 2001-08-03
Clearance details
- K-number
- K012200
- Device name
- 1.5T INFINITY TWINSPEED MR SYSTEM
- Applicant
- GE Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2001-07-13
- Decision date
- 2001-08-03
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Milwaukee, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Signa 1.5T TwinSpeed Magnetic Resonance Imaging System recall (Z-0857-2022) | GE Healthcare, LLC | 2022-04-04 |
| GE Healthcare, Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; recall (Z-2339-2015) | GE Healthcare | 2015-08-05 |
| GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EX recall (Z-1305-2015) | GE Healthcare | 2015-03-20 |
| This correction applies to all GE Healthcare MRI systems with superconducting magnets: Dis recall (Z-1035-2015) | GE Healthcare | 2015-02-18 |