510(k) K231162
- Device
- ROSA Hip System
- Applicant
- Orthosoft Inc (D/B/A Zimmer Cas)
- 510(k) number
- K231162
- Product code
- LLZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-05-23
- Date received
- 2023-04-24
- Regulation
- 892.2050
- Classification name
- System, Image Processing, Radiological
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Victorien Thiaux
- Address
- 75 Queen St., Suite 3300 Montreal CA H3C 2N6 H3C 2N6
FDA Registration Numbers#
- 3016851379
- 3025308066
- 3013912897
- 3011189058
- 1226773
- 3015185750
- 3042248552
- 9710645
- 3018302800
- 3005945241
- 3013306229
- 3015173183
- 3016007746
- 3013342228
- 3017944270
- 3010956703
- 3012761544
- 3030409224
- 3010146120
- 9611992
- 1125622
- 3004962788
- 1061158
- 9681475
- 3003775006
- 3006579682
- 3009341091
- 3014678441
- 3014809646
- 3011706018
- 3012470322
- 3023003446
- 3007441485
- 3038189169
- 3038011206
- 1064588
- 3006611212
- 3011471624
- 3017263724
- 3014132130
- 3004485675
- 3004915908
- 3030088963
- 3016075969
- 3042940623
- 3000237660
- 3003370689
- 3003898228
- 3030446518
- 3021559833
- 3044519982
- 3001722928
- 9613445
- 3004016520
- 3006551157
- 3009293341
- 3009185973
- 3008548323
- 3012516536
- 3005450718
- 3019252669
- 3003574171
- 3016607092
- 3005180920
- 3012911444
- 8010177
- 3010685285
- 3011521456
- 3015169361
- 9680215
- 2134265
- 3005940400
- 3024078470
- 3014483751
- 3005406110
- 3013660213
- 3011063460
- 3014343888
- 3016727312
Source Documents#
Other 510(k) Records For Product Code LLZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K253899 | 3D-Anywhere | Provect.AI | 2026-07-09 |
| K261465 | INDIRA CLOUD VIEWER | INDIGO TECHNOLOGIES | 2026-07-06 |
| K260576 | MeVis AVM Contour | MeVis Medical Solutions AG | 2026-06-30 |
| K260231 | MiPACS V5 (1.0.0) | Apryse Software Corp | 2026-06-25 |
| K253421 | Perfusion Measurement Platform v1 | Quantified Imaging Limited | 2026-06-22 |
| K261352 | 2D Hip Planning Software | One Ortho | 2026-06-08 |
| K260116 | CustoMED Viewer | CustoMED , Ltd. | 2026-06-03 |