INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500
FDA 510(k) clearance K040050 · decided 2004-03-24
Clearance details
- K-number
- K040050
- Device name
- INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500
- Applicant
- Ge Medical Systems Navigation and Visualization IN
- Decision
- Substantially Equivalent
- Date received
- 2004-01-12
- Decision date
- 2004-03-24
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Mode recall (Z-1985-2012) | GE OEC Medical Systems, Inc | 2012-07-12 |
| Transmitter Sensor Cables, Part Numbers: 1002008, 1004587, 1007914-NAV, GE Healthcare Surg recall (Z-1941-2011) | GE OEC Medical Systems, Inc | 2011-04-11 |
| Receiver Sensor Cables, Part Numbers: 1001989, 1001990, 1004069, 1007907-NAV, GE Healthcar recall (Z-1942-2011) | GE OEC Medical Systems, Inc | 2011-04-11 |
| InstaTrak 3500 Plus Navigation and Visualization System recall (Z-0815-05) | GE OEC Medical Systems,Inc | 2005-05-11 |
| InstaTrak 3500 Plus Navigation and Visualization System recall (Z-0691-05) | OEC Medical Systems, Inc | 2005-04-08 |
| Spine Clamp, an accessory to the InstaTrak 3500 Plus system. Clamp is attached to the spin recall (Z-0155-05) | GE OEC Medical Systems,Inc | 2004-11-03 |