1273089
Radiology Information Systems, Inc. — FEI 3002952981
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 18, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Dulles, VA (United States)
Citations
| ID | CFR | Description |
| 22795 | 21 CFR 801.20(a) | Label to bear a unique device identifier |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3665 | 21 CFR 820.20(b)(3) | Management representative |