K230856
- 510(k) number
- K230856
- Device name
- BrainSpec Core Software
- Applicant
- Brainspec, Inc. MA · US
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2023-11-14
- Date received
- 2023-03-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K230856.pdf
Official FDA record: K230856
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.