K251168
- 510(k) number
- K251168
- Device name
- Image Suite
- Applicant
- Carestream Health, Inc. NY · US
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2025-09-04
- Date received
- 2025-04-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K251168.pdf
Official FDA record: K251168
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.