K244016
- 510(k) number
- K244016
- Device name
- iPETcertum (v1.0)
- Applicant
- Claritas Healthtech Pte, Ltd. SG
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2025-08-05
- Date received
- 2024-12-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K244016.pdf
Official FDA record: K244016
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.