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#
- 3013410552
- 3021032044
- 3015232217
- 8043933
- 3015169361
- 3021982861
- 3024812789
- 3036758982
- 3025309924
- 3017927156
- 3007545404
- 3007120336
- 3019834893
- 3004526608
- 3031194398
- 3022745617
- 3016686005
- 2126677
- 3022719374
- 3002808157
- 3004363352
Source Documents#
Other 510(k) Records For Product Code LLZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254265 | Helion Viewer Suite | Videomed Srl ( a Baxter Healthcare Corp company) | 2026-05-27 |
| 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 |
Legacy Summary#
summary
FDA Review#
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