IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200
FDA 510(k) clearance K093146 · decided 2009-11-30
Clearance details
- K-number
- K093146
- Device name
- IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200
- Applicant
- Veran Medical Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-10-05
- Decision date
- 2009-11-30
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- JAK
- Device class
- 2
- Regulation number
- 892.1750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 2 recall (Z-2659-2023) | Olympus Corporation of the Americas | 2023-09-29 |
| Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (incl recall (Z-2661-2023) | Olympus Corporation of the Americas | 2023-09-29 |
| Veran : Endobronchial Models: INS-5500 View Optical Probe INS-5450 SPiN Xtend 21ga, 1.8 OD recall (Z-2662-2023) | Olympus Corporation of the Americas | 2023-09-29 |
| Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, recall (Z-2663-2023) | Olympus Corporation of the Americas | 2023-09-29 |
| Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, recall (Z-2664-2023) | Olympus Corporation of the Americas | 2023-09-29 |