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#
- 3003412859
- 3036725840
- 3023217364
- 8043933
- 3016851379
- 3021637148
- 3010132318
- 3026391019
- 3045159436
- 9615992
- 3023266032
- 3017936978
- 3017489096
- 3003768277
- 3003402534
- 3004526608
- 3048085746
- 3008027912
- 1826555
- 3006115340
- 3004884150
- 9614977
- 3007137598
- 3006990600
- 1717344
- 3017435704
- 3025308066
- 3012322232
- 1000432246
- 3011114764
- 3009238185
- 3004063527
- 3014055202
- 3013077751
- 3010656400
- 3006551157
- 3006551230
- 3011724582
- 3009134655
- 3010687441
- 3000219976
- 3008962159
- 3014678441
- 3009246966
- 3016244609
- 2221819
- 3006894636
- 3004497354
- 2954921
- 3006209933
- 3031755019
- 3008481104
- 3011213614
- 3014639846
- 3042655017
- 3006165530
- 8020021
- 3003370689
- 3014262693
- 2133772
- 2134213
- 3005061536
- 1834331
- 3013868968
- 3009973505
- 1818910
- 1825014
- 3017233423
- 3004504920
- 3010197287
- 3020331900
- 9681475
- 3009555440
- 3009293341
- 3011501361
- 3020162557
- 3014470527
- 3011853771
- 3006123366
Source Documents#
Other 510(k) Records For Product Code LLZ #
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|---|---|---|---|
| K263048 | Syngo Carbon Space (VA4) | Siemens Healthineers AG | 2026-09-29 |
| K261874 | Syneris PACS v.1.0.1.0 | Syneris | 2026-09-23 |
| K262442 | HipStudio Analysis | Replasia BV | 2026-09-22 |
| K261855 | Elucid PlaqueIQ | Elucid Bioimaging, Inc. | 2026-09-18 |
| K254214 | OOOPDS | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | 2026-09-15 |
| K261861 | SPINEsim v1.0 | Mdsim S.A. | 2026-09-15 |
| K262060 | 3D-RD-S | Radiopharmaceutical Imaging & Dosimetry, LLC | 2026-09-04 |
| K261500 | KBA3D (v2.4.0) | S.M.A.I.O | 2026-08-17 |
| K262449 | AdvaView | ADVAHEALTH SOLUTIONS, LLC | 2026-08-14 |
| K261916 | NeuroQuant PET | Cortechs Labs, Inc. | 2026-08-12 |
| K260936 | RadioViewAI | Neurocareai, Inc. (Dba Savelife.Ai) | 2026-07-31 |
| K260588 | Cleerly LABS | Cleerly, Inc. | 2026-07-29 |
| K262462 | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | 2026-07-24 |
| K262143 | ImageGrid StreamVue | Candelis, Inc. | 2026-07-23 |
| K260500 | ResolutionMD | ResolutionMD, Inc. | 2026-07-21 |
Legacy Summary#
summary
FDA Review#
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