SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY
FDA 510(k) clearance K013636 · decided 2002-01-24
Clearance details
- K-number
- K013636
- Device name
- SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY
- Applicant
- GE Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2001-11-05
- Decision date
- 2002-01-24
- Days to decision
- 80 days
- Clearance type
- Traditional
- 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 3.0T. Product Usage: Magnetic resonance system for diagnostic imaging recall (Z-0255-2016) | GE Healthcare | 2015-11-10 |
| 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 |
| 9) Signa Excite 1.5 T (Excite II) (K013636 Signa Infinity MR System with EXCITE Technology recall (Z-1432-2011) | GE Healthcare, LLC | 2011-02-24 |
| Signa Excite" 1.5 T Magnetic Resonance Systems, manufactured by GE Healthcare, P.O. Box 44 recall (Z-0462-2011) | GE Healthcare, LLC | 2010-11-24 |