GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM
FDA 510(k) clearance K030874 · decided 2003-03-28
Clearance details
- K-number
- K030874
- Device name
- GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM
- Applicant
- General Electric Co.
- Decision
- Substantially Equivalent
- Date received
- 2003-03-20
- Decision date
- 2003-03-28
- Days to decision
- 8 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 |
|---|---|---|
| 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 |
| SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCI recall (Z-1943-2013) | GE Healthcare, LLC | 2013-08-09 |
| 8) Signa 3.0T Infinity with EXCITE (K030874 GE 3.0T Signa Infinity TwinSpeed with EXCITE M recall (Z-1431-2011) | GE Healthcare, LLC | 2011-02-24 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S017) | General Electric Co. | 1988-07-29 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S013) | General Electric Co. | 1988-07-15 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S016) | General Electric Co. | 1988-06-30 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S014) | General Electric Co. | 1988-05-05 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S015) | General Electric Co. | 1988-05-02 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S012) | General Electric Co. | 1987-11-25 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S011) | General Electric Co. | 1987-06-18 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S010) | General Electric Co. | 1987-03-30 |