510(k) K093146 ยท JAK System, X-Ray, Tomography, Computed
IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200
| Applicant | Veran Medical Technologies, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Nov 30, 2009 |
| Received | Oct 5, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093146
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2023 | Olympus Corporation of the Americas Veran:SPiN Thoracic Navigation System
Models:
SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz
SYS-4000 SPiN Thoracic Navigation System
SYS-3230 ig4 System, 230V, 50Hz / SPiN Thoracic Na Open, Classified |
JAK | None listed |
| Sep 29, 2023 | Olympus Corporation of the Americas Veran : Percutaneous
Models:
INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)"
INS-5611 SPiN Perc Localization Needle - 2cm, 5/Bx
INS-5610 SPiN Perc Localization N Open, Classified |
JAK | None listed |
| Sep 29, 2023 | Olympus Corporation of the Americas Veran : Endobronchial
Models:
INS-5500 View Optical Probe
INS-5450 SPiN Xtend 21ga, 1.8 OD, 5/Bx
INS-5440 View Peripheral Catheter, 3.8mm OD, 2.5mm WC
INS-5411 0.016" Stylet, 1235 mm L, Open, Classified |
JAK | None listed |
| Sep 29, 2023 | Olympus Corporation of the Americas Veran : Percutaneous Always on Track
Models:
INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga
INS-5039 Always-On vTrack Universal Tracker, SM/CL, 12-18ga
INS-5036 "22 UTW 125mm Always- Open, Classified |
JAK | None listed |
| Sep 29, 2023 | Olympus Corporation of the Americas Veran : Endobronchial Always on Track
Models:
INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX
INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx
INS-0372 AOTT Serrated Forceps, 1.8mm OD, 5/Bx Open, Classified |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.