3 devices · 2 companies · 2021 to 2022
Product code MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)
3 devices under product code MQB, 2021 to 2022, from 2 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (3 of 3 here), the regulation, and MAUDE report counts by product code.
Solid State X-Ray Imager (Flat Panel/Digital Imager). 21 CFR 892.1680, Class II. MAUDE held 1,282 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Eclipse II with Smart Noise CancellationK213307 · 510(k) | Carestream Health, Inc. | Radiology | database entry | |
| Intelligent NRK212269 · 510(k) | Canon Inc. | Radiology | database entry | |
| Eclipse II with Smart Noise CancellationK202441 · 510(k) | Carestream Health, Inc. | Radiology | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.