510(k) K223071
- Device
- Xenoview VDP
- Applicant
- Polarean, Inc.
- 510(k) number
- K223071
- Product code
- LLZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-12-23
- Date received
- 2022-09-30
- 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
- Neil Wadehra
- Address
- P.O. Box 14805 Research Triangle Park NC US 27709 27709
FDA Registration Numbers#
- 3007697958
- 3004009431
- 3018405359
- 9615916
- 3006172536
- 3013660213
- 3012322232
- 3038187462
- 3010111497
- 3007137598
- 3032014234
- 2518586
- 3015200693
- 1836549
- 3026309987
- 3010728558
- 3011713193
- 3010331645
- 3011713200
- 3007120336
- 3015537315
- 3007993775
- 3014954414
- 3005075696
- 3006115340
- 3003898228
- 3019269298
- 3014809646
- 3008364043
- 3033525986
- 3014262693
- 3032579549
- 3014483751
- 3005180920
- 3011015597
- 3014146081
- 3015158050
- 3044519982
- 3013077751
- 3016438694
- 3030982377
- 3008962159
- 9617592
- 3040602603
- 9617978
- 9611896
- 3014833795
- 3016110967
- 3042204491
- 3047907228
- 9614587
- 3016727312
- 3003781339
- 3011063460
- 3008481104
- 3038136528
- 3014665798
- 9611992
- 2433615
- 3005207094
- 9616389
- 3009302839
- 3009341091
- 3003596442
- 3016555232
- 3011853771
- 3005778458
- 3004555721
- 3011676026
- 3009246966
- 3030228551
- 8020825
- 3004434200
- 3003769120
- 1834331
- 3014678441
- 9680028
- 3023546785
- 3011189058
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 |