INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500
FDA 510(k) clearance K003510 · decided 2001-02-12
Clearance details
- K-number
- K003510
- Device name
- INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500
- Applicant
- Visualization Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-11-14
- Decision date
- 2001-02-12
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Wilmington, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| OEC InstaTrak 3500, picture archiving and communications system intended as an aid to loca recall (Z-2236-2012) | GE OEC Medical Systems, Inc | 2012-08-22 |
| InstaTrak 3500 Navigation and Visualization System recall (Z-0690-05) | OEC Medical Systems, Inc | 2005-04-08 |