INSTATRAK 3000
FDA 510(k) clearance K983529 · decided 1998-12-31
Clearance details
- K-number
- K983529
- Device name
- INSTATRAK 3000
- Applicant
- Visualization Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-10-08
- Decision date
- 1998-12-31
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- North Attleboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (I recall (Z-2251-2012) | GE OEC Medical Systems, Inc | 2012-08-28 |
| InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anato recall (Z-0704-2007) | GE OEC Medical Systems,Inc | 2007-03-30 |
| GE Healthcare Navigation Pin Transmitter (GE P/N 1004070) -Medical Systems InstaTrak Pin T recall (Z-0709-06) | GE OEC Medical Systems,Inc | 2006-04-07 |
| InstaTrak 3500 Navigation and Visualization System recall (Z-0814-05) | GE OEC Medical Systems,Inc | 2005-05-11 |
| InstaTrak 3500 Plus Navigation and Visualization System recall (Z-0815-05) | GE OEC Medical Systems,Inc | 2005-05-11 |
| InstaTrak 3000 Navigation and Visualization System recall (Z-0689-05) | OEC Medical Systems, Inc | 2005-04-08 |