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- MiscellaneousMiscellaneous
- PCSLiver Iron Concentration Imaging Companion Diagnostic For Deferasirox2Product Code
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HeartFocus (V.1.1.1)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K242807
- 510(k) Type
- Traditional
- Applicant
- Deski
- Country
- France
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/4/2025
- Days to Decision
- 199 days
- Submission Type
- Summary