510(k) K220733
- Device
- OptiVu ROSA MxR
- Applicant
- Orthosoft, Inc. (d/b/a Zimmer CAS)
- 510(k) number
- K220733
- Product code
- LLZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-07-29
- Date received
- 2022-03-14
- Regulation
- 892.2050
- Classification name
- System, Image Processing, Radiological
- Medical specialty
- Radiology
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Paul Hardy
- Address
- 75 Queen St. Suite 3300 Montreal CA H3C 2N6 H3C 2N6
FDA Registration Numbers#
- 3036756245
- 8043792
- 3013552417
- 3016676864
- 3020703212
- 3025287527
- 9681465
- 3016566146
- 9617840
- 3006946276
- 3007441485
- 3005180920
- 3010163695
- 8010468
- 3043520095
- 8043933
- 3006017180
- 3016571711
- 3033509898
- 3004142400
- 3008110533
- 3016534677
- 3008869747
- 3010047454
- 3015151147
- 3010031846
- 3010197287
- 3009973505
- 3014232530
- 3016438694
- 3019878658
- 1526534
- 2032098
- 3025603301
Source Documents#
Other 510(k) Records For Product Code LLZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253831 | CMN Capillary Function with Virtual Expert for MRI, CT and CBCT | Cercare Medical A/S | 2026-05-18 |
| K254013 | SubtleHD-PET (1.x) | Subtle Medical, Inc. | 2026-05-14 |
| K260321 | HipGuide (V 1.0.0.0) | Orthopedic Driven Imaging, LLC | 2026-05-08 |
| K260716 | Neowise | Cefla S.C. | 2026-05-04 |
| K260009 | LungPoint Virtual Bronchoscopic Navigation (VBN) Software | Broncus Medical, Inc. | 2026-04-24 |
| K254237 | CCI PACS VIEWER (PACS-US-001) | CliniComp, Intl. | 2026-04-23 |
| K253029 | RW-1 | Mediott, Inc. | 2026-03-31 |
| K253950 | Avatar Medical Vision | Avatar Medical | 2026-03-30 |
| K252195 | ARTICOR planner | Artiness S.R.L | 2026-03-27 |
| K260479 | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | 2026-03-13 |
| K253111 | Aeka Imaging | Good Methods Global, Inc. | 2026-03-13 |
| K251964 | Mimics Thoracic Planner | Materialise NV | 2026-03-12 |
| K253486 | SKIA-Head (Model: SKIA-ST00) | Skia, Inc. | 2026-02-23 |
| K260205 | AS Software Version Asera | AS Software, LLC | 2026-02-19 |
| K253927 | LiveMedica Enterprise PACS | Live Medica, LLC | 2026-02-06 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases