K241312
- 510(k) number
- K241312
- Device name
- TeraRecon Cardiac.Chambers.MR (1.0.0)
- Applicant
- Terarecon,Inc. NC · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2024-11-05
- Date received
- 2024-05-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K241312.pdf
Official FDA record: K241312
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.