Mirada Rt
510(k) K102687
Mirada Rt is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Mirada Medical, Ltd., cleared under FDA 510(k) K102687 on 4 Oct 2010, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK102687 | Date4 Oct 2010 | StatusActive |
Official records
- FDA 510(k) database K102687
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K102687
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| XD 3.6 | 3.6 | B334XD3P60 | — | On the market |
| XD Nuclear Medicine 4.2 | 4.2 | B334NMX4P20 | — | On the market |
| XD Nuclear Medicine 4.4 | 4.4 | B334NMX4P40 | — | On the market |
Similar devices
Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).
- CLARISO PACS by Clariso, Inc.
- AmCAD-UV by AMCAD BIOMED CORPORATION
- DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0) by Howtek, Inc.
- RConsole1 1.0 by Drtech Corp.
- LUCION by Mevisys Co., Ltd.
- Synapse 3D Base Tools v6.6 by FUJIFILM CORPORATION
- E4D COMPASS by D4D Technologies
- PLUG 'N VIEW 3D, VERSION 1.0 by Voxar Limited
- MODIFICATION TO ENCOMPASS by Heartlab, Inc.
- NIO 3MP-21 by Barcoview