K241121
- 510(k) number
- K241121
- Device name
- MICSI-RMT
- Applicant
- Microstructure Imaging, Inc. NY · US
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2024-07-17
- Date received
- 2024-04-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K241121.pdf
Official FDA record: K241121
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.