IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)— 510(k) K241346
Substantially EquivalentAspen Imaging Healthcare, Inc.
FDA 510(k) clearance K241346 for IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector), Substantially Equivalent on 2024-11-07. Applicant: Aspen Imaging Healthcare, Inc.. Device class: 2.
Clearance details
- Applicant
- Aspen Imaging Healthcare, Inc.
- Product code
- Code MQB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plano, TX, US
Recent devices under product code MQB
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