510(k) K040050
- Device
- INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500
- Applicant
- GE MEDICAL SYSTEMS NAVIGATION AND VISUALIZATION IN
- 510(k) number
- K040050
- Product code
- LLZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-03-24
- Date received
- 2004-01-12
- Regulation
- 892.2050
- Classification name
- System, Image Processing, Radiological
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JEFF WAGNER
- Address
- 384 Wright Brothers Dr. Salt Lake City UT US 84116 84116
FDA Registration Numbers#
- 3009717300
- 3000190675
- 3010626822
- 3010146120
- 3003574171
- 1226003
- 3013634985
- 3013497030
- 3010656400
- 3018064242
- 3023546785
- 3011545155
- 3013844297
- 9611992
- 3006990600
- 3017944270
- 3015425142
- 3042204491
- 3003596442
- 3036471119
- 3007120336
- 3016567400
- 3013535906
- 3017167291
- 3007603826
- 3009302839
- 3007795813
- 3014809646
- 3010445368
- 3029906636
- 3011713200
- 1836549
- 3001722928
- 3005919188
- 3030179922
- 3004884150
- 3021233709
- 3006115340
- 1724955
- 3003757027
- 8030876
- 3010956703
- 3009117933
- 3004755841
- 3030979155
- 3007697958
- 9615439
- 3017936680
- 3003768251
- 3011824442
- 3019216
- 3034604691
- 1066019
- 2433615
- 3006013411
- 3004153896
- 3004198450
- 3000219976
- 3025394753
- 3021551875
- 3001675293
- 3008012314
- 3010822102
- 1043653
- 2027467
- 1720929
- 3004526608
- 3004765453
- 1644408
- 3018733944
- 3027347389
- 3004187715
- 3016450069
- 3007194257
- 3030655434
- 1828464
- 3015464948
- 3017123055
- 3004063527
Source Documents#
Other 510(k) Records For Product Code LLZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254265 | Helion Viewer Suite | Videomed Srl ( a Baxter Healthcare Corp company) | 2026-05-27 |
| K253831 | CMN Capillary Function with Virtual Expert for MRI, CT and CBCT | Cercare Medical A/S | 2026-05-18 |
| K254013 | SubtleHD-PET (1.x) | Subtle Medical, Inc. | 2026-05-14 |
| K260321 | HipGuide (V 1.0.0.0) | Orthopedic Driven Imaging, LLC | 2026-05-08 |
| K260716 | Neowise | Cefla S.C. | 2026-05-04 |
| K260009 | LungPoint Virtual Bronchoscopic Navigation (VBN) Software | Broncus Medical, Inc. | 2026-04-24 |
| K254237 | CCI PACS VIEWER (PACS-US-001) | CliniComp, Intl. | 2026-04-23 |
| K253029 | RW-1 | Mediott, Inc. | 2026-03-31 |
| K253950 | Avatar Medical Vision | Avatar Medical | 2026-03-30 |
| K252195 | ARTICOR planner | Artiness S.R.L | 2026-03-27 |
| K260479 | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | 2026-03-13 |
| K253111 | Aeka Imaging | Good Methods Global, Inc. | 2026-03-13 |
| K251964 | Mimics Thoracic Planner | Materialise NV | 2026-03-12 |
| K253486 | SKIA-Head (Model: SKIA-ST00) | Skia, Inc. | 2026-02-23 |
| K260205 | AS Software Version Asera | AS Software, LLC | 2026-02-19 |
Legacy Summary#
summary
FDA Review#
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