510(k) K170816
- Device
- Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM
- Applicant
- Brainlab AG
- 510(k) number
- K170816
- Product code
- LLZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-09-26
- Date received
- 2017-03-20
- 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
- Rainer Birkenbach
- Address
- Olof-Palme-Str 9 Munich DE 81829 81829
FDA Registration Numbers#
- 3003935342
- 3025602618
- 2937707
- 3026606306
- 3029877582
- 3007301305
- 3017140520
- 3010160527
- 3014809646
- 3022435840
- 3021551875
- 3007362683
- 3010885402
- 3014004349
- 3005172103
- 1826555
- 3004063527
- 3023385454
- 3035707772
- 3004009431
- 3017123055
- 3015276088
- 3011545155
- 3018788582
- 3010684280
- 3016678045
- 1226188
- 3031755019
- 3006551230
- 3016567400
- 3013682146
- 3004504920
- 9610617
- 3033527241
- 3044519982
- 3004951433
- 3030412764
- 3042175844
- 3017426576
- 3011063460
- 3007993775
- 3016461002
- 9614209
- 3003768251
- 3007809729
- 3015763655
- 9615439
- 3015777306
- 3009238185
- 3014146081
- 3019544554
- 3007137598
- 3030446518
- 8030233
- 3035455070
- 3016555232
- 3016607092
- 9680215
- 3016090213
- 3042940623
- 3004756607
- 3017167291
- 3008962159
- 9617978
- 3014491269
- 9611992
- 9710602
- 9614698
- 3010956703
- 3015168097
- 2183449
- 3009302839
- 3031024978
- 3017155477
- 3004537781
- 3007441485
- 3026391019
- 3009601121
- 3021559833
Source Documents#
Other 510(k) Records For Product Code LLZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K262120 | Avara Viewer | Avara Software | 2026-07-10 |
Legacy Summary#
summary
FDA Review#
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