510(k) K241346
K241346 is an FDA 510(k) premarket notification submitted by Aspen Imaging Healthcare, Inc. for the device "IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)". The FDA issued a decision of Substantially Equivalent on November 7, 2024. The device falls under product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)), a Class II device regulated under 21 CFR 892.1680. Aspen Imaging Healthcare, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 7, 2024
- Date Received
- May 13, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type