510(k) K181572
K181572 is an FDA 510(k) premarket notification submitted by Mirada Medical, Ltd. for the device "Workflow Box". The FDA issued a decision of Substantially Equivalent on Jul 10, 2018. The device falls under product code QKB (Radiological Image Processing Software For Radiation Therapy), a Class II device regulated under 21 CFR 892.2050. Mirada Medical, Ltd. has 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 10, 2018
- Date Received
- Jun 14, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Radiological Image Processing Software For Radiation Therapy
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type
- 510(k)
To provide semi-automatic or fully-automated radiological image processing and analysis tools for radiation therapy. Software implementing artificial intelligence (AI) including nonadaptive machine learning algorithms trained with clinical and/or artificial radiological images. In these devices, the algorithm training images typically impact device performance. AI based radiological image processing software is intended to be used in the workflow of radiation therapy. Adaptive AI algorithms are not within the scope of this product code. Primary radiation dose calculation or plan optimization for treatment planning are not within scope of this product code.