510(k) K161634
- Device
- IPS CaseDesigner
- Applicant
- NOBEL BIOCARE AB
- 510(k) number
- K161634
- Product code
- LLZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-11-10
- Date received
- 2016-06-14
- 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
- CHARLEMAGNE CHUA
- Address
- Vastra Hamngatan 1 Goteborg SE SE-411 17 SE-411 17
FDA Registration Numbers#
- 3014954414
- 3009196021
- 2954921
- 3004485675
- 3009555447
- 3009555440
- 9610482
- 3025343020
- 3009717300
- 9616251
- 3013718526
- 9614698
- 3007120336
- 3007339076
- 3015612252
- 3025603301
- 3015383864
- 3011015597
- 3018064242
- 3015806723
- 2936485
- 3015537315
- 3007305589
- 3005930550
- 3032807464
- 3030446846
- 3003768251
- 1000314502
- 3007038409
- 3000190675
- 3004504920
- 3005496266
- 3004063527
- 3010493171
- 3023245
- 3015168097
- 3017004860
- 3024185724
- 3001675293
- 3009973505
- 3021032044
- 3034604691
- 3009156722
- 3015231789
- 2433615
- 3025308066
- 8030233
- 3038136320
- 3004951433
- 3006551230
- 3016954909
- 8030128
- 3010445368
- 3018302800
- 3012939903
- 3012075008
- 3015224777
- 3004730352
- 9611343
- 3007362683
- 3017654247
- 3025442726
- 3038189169
- 1064588
- 3036756245
- 3043532712
- 3013427569
- 3005877899
- 1717344
- 3016438694
- 3016461002
- 3015232217
- 3016851379
- 3011307657
- 1047843
- 9615992
- 3006115340
- 3006551157
- 2952596
Source Documents#
Other 510(k) Records For Product Code LLZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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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