6 devices · 5 companies · 2014 to 2025
Product code KPR: System, X-Ray, Stationary
6 devices under product code KPR, 2014 to 2025, from 5 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (6 of 6 here), the regulation, and MAUDE report counts by product code.
System, X-Ray, Stationary. 21 CFR 892.1680, Class II. MAUDE held 1,233 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 |
|---|---|---|---|---|
| uDR Aurora CXK251167 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | database entry | |
| Definium Tempo SelectK250788 · 510(k) | GE Hualun Medical Systems Co., Ltd | Radiology | database entry | |
| YSIO X.preeK250738 · 510(k) | Siemens Medical Solutions | Radiology | database entry | |
| Radiography 7300 CK233662 · 510(k) | Philips Medical Systems DMC GmbH | Radiology | database entry | |
| YSIO X.preeK233543 · 510(k) | Siemens Medical Solutions | Radiology | database entry | |
| YSIO MAXK133259 · 510(k) | SIEMENS MEDICAL SOLUTIONS USA, 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.