K243842
- 510(k) number
- K243842
- Device name
- Intra-Operative Positioning System (IOPS®)
- Applicant
- Centerline Biomedical, Inc. OH · US
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2025-03-06
- Date received
- 2024-12-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.9 MB · U.S. public domain
Also available from FDA: K243842.pdf
Official FDA record: K243842
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.