FDA Inspection 1334778 — X-Ray Systems, Inc.
The FDA completed an inspection of X-Ray Systems, Inc. on Sep 3, 2026 in Crystal Lake, IL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Sep 3, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Crystal Lake, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23132 | ISO 13485:2016 Clause 7.3.9 | Design and development changes not identified |