K241346
- 510(k) number
- K241346
- Device name
- IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)
- Applicant
- Aspen Imaging Healthcare, Inc. TX · US
- Product code
- MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Decision date
- 2024-11-07
- Date received
- 2024-05-13
- 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: K241346.pdf
Official FDA record: K241346
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.