| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3171 | 21 CFR 820.198(b) | Rationale documented for no investigation |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 5008 | 21 CFR 1002.20(a) | Failure to report |
| 5012 | 21 CFR 1003.10(a) | FDA not notified of defect or noncompliance |
| 5013 | 21 CFR 1003.10(b) | Dealers, distributors, purchasers not notified |
| 5019 | 21 CFR 1004.1 | CAP not submitted |
| 5034 | 21 CFR 1010.2(c) | Certification not based on adequate test/testing program |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 5465 | 21 CFR 1020.30(h)(4)(i) | leakage technique factors, beam limiting device |
| 5472 | 21 CFR 1020.30(k) | Compliance measurements--diagnostic source assembly |
| 5700 | 21 CFR 1002.10 | Failure to submit, distinct marking |
| 5749 | 21 CFR 1020.33(f)(1) | CT conditions of operation indicated prior to scan |
| 5763 | 21 CFR 1020.33(c)(3) | Performance data for CT conditions of operation - incomplete |
| 5765 | 21 CFR 1020.33(c)(2)(ii) | CTDI for conditions of operation which vary exposure |
| 5767 | 21 CFR 1020.33(c)(2)(i)(c) | CTDI at 90, 180, 270 degrees |
| 5903 | 21 CFR 1020.30(c) | Combination of two or more components |
| 5907 | 21 CFR 1020.30(d)(1) | Report of assembly submitted within 15 days |
| 5911 | 21 CFR 1020.30(h)(2)(i) | Tube housing assembly mandatory information |
| 5914 | 21 CFR 1020.30(h)(3)(i) | Rated line voltage, range (x-ray control + generator) |
| 5915 | 21 CFR 1020.30(h)(3)(ii) | Maximum line current (x-ray control + generator) |
| 5919 | 21 CFR 1020.30(h)(3)(v) | Generator rating and duty cycle |
| 5921 | 21 CFR 1020.30(h)(3)(vi) | Fixed technique factors--max deviation from nominal |
| 5923 | 21 CFR 1020.30(h)(3)(viii) | Measurement criteria for technique factors |
| 5924 | 21 CFR 1020.30(h)(4)(i) | Beam limiting devices--leakage technique factors |