FDA 510(k) ClearanceLLZ
SPINEsim v1.0
FDA 510(k) K261861 · Mdsim S.A.
Clearance details
Ask AI- 510(k) number
- K261861
- Device name
- SPINEsim v1.0
- Applicant
- Mdsim S.A.
- Product code
- LLZ
- Decision
- Substantially Equivalent
- Decision date
- Device class
- Class 2
- Regulation number
- 892.2050
- Advisory committee
- RA
- Medical specialty
- Radiology
Candidate predicate devices
Ask AIOther devices cleared under product code LLZ form a screening cohort, not a predicate determination. Compare intended use, technological characteristics, performance evidence, labeling, and current legal-marketing status before selecting a predicate.
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K263048 | Syngo Carbon Space (VA4) | Siemens Healthineers AG | |
| K261874 | Syneris PACS v.1.0.1.0 | Syneris | |
| K262442 | HipStudio Analysis | Replasia BV | |
| K261855 | Elucid PlaqueIQ | Elucid Bioimaging, Inc. | |
| K254214 | OOOPDS | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | |
| K262060 | 3D-RD-S | Radiopharmaceutical Imaging & Dosimetry, LLC | |
| K261500 | KBA3D (v2.4.0) | S.M.A.I.O | |
| K262449 | AdvaView | ADVAHEALTH SOLUTIONS, LLC | |
| K261916 | NeuroQuant PET | Cortechs Labs, Inc. | |
| K260936 | RadioViewAI | Neurocareai, Inc. (Dba Savelife.Ai) | |
| K260588 | Cleerly LABS | Cleerly, Inc. |
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