510(k) K181572
- Device
- Workflow Box
- Applicant
- Mirada Medical Ltd.
- 510(k) number
- K181572
- Product code
- LLZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-07-10
- Date received
- 2018-06-14
- 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
- Yes
Applicant Contact#
- Contact
- Gwilym Owen
- Address
- Oxford Centre For Innovation, New Rd. Oxford GB ox1 iby ox1 iby
FDA Registration Numbers#
- 3015232217
- 8043933
- 3036758982
- 3017927156
- 3024812789
- 3013410552
- 3004363352
- 3007120336
- 3004526608
- 2126677
- 3016686005
- 3002808157
- 3015169361
- 3007545404
- 3022719374
- 3021982861
- 3019834893
- 3022745617
- 3031194398
- 3021032044
- 2183553
- 3006894636
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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