EXPD-N series
Model EXPD 4343NP · DRTECH Corporation · DI 08800018430408
MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager) · Class II · 21 CFR 892.1680
UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-02 | 0 | 2 |
| 2019-04 | 0 | 2 |
| 2019-05 | 0 | 1 |
| 2019-06 | 0 | 2 |
| 2019-07 | 0 | 3 |
| 2019-08 | 0 | 1.5 |
| 2019-10 | 0 | 1 |
| 2019-12 | 0 | 6 |
| 2020-01 | 0 | 1 |
| 2020-08 | 0 | 1 |
| 2020-09 | 0 | 1.5 |
| 2020-10 | 0 | 1 |
| 2020-12 | 0 | 1 |
| 2021-01 | 0 | 3 |
| 2021-02 | 0 | 2 |
| 2021-03 | 0 | 1 |
| 2021-04 | 0 | 2 |
| 2021-06 | 0 | 2 |
| 2021-08 | 0 | 1 |
| 2021-11 | 0 | 2 |
| 2021-12 | 0 | 1.5 |
| 2022-01 | 0 | 2 |
| 2022-04 | 0 | 2 |
| 2022-07 | 0 | 6 |
| 2022-09 | 0 | 1 |
| 2022-10 | 0 | 1 |
| 2022-12 | 0 | 2 |
| 2023-01 | 0 | 3 |
| 2023-02 | 0 | 1.5 |
| 2023-03 | 0 | 2 |
| 2023-04 | 0 | 2.5 |
| 2023-05 | 0 | 2 |
| 2023-06 | 0 | 4.4 |
| 2023-07 | 0 | 2.71 |
| 2023-08 | 0 | 1.86 |
| 2023-09 | 0 | 2.5 |
| 2023-10 | 0 | 2.67 |
| 2023-11 | 0 | 2 |
| 2023-12 | 0 | 3 |
| 2024-01 | 0 | 3.5 |
| 2024-02 | 0 | 2.25 |
| 2024-03 | 0 | 3.2 |
| 2024-04 | 0 | 8.33 |
| 2024-05 | 0 | 3 |
| 2024-06 | 0 | 1.33 |
| 2024-07 | 0 | 2.75 |
| 2024-08 | 0 | 3.67 |
| 2024-09 | 0 | 3.25 |
| 2024-10 | 0 | 4.5 |
| 2024-11 | 0 | 3.75 |
| 2024-12 | 0 | 2.33 |
| 2025-01 | 0 | 5.67 |
| 2025-02 | 0 | 6.5 |
| 2025-03 | 0 | 2.63 |
| 2025-04 | 0 | 3 |
| 2025-05 | 0 | 3.75 |
| 2025-06 | 0 | 2.67 |
| 2025-07 | 0 | 3.4 |
| 2025-08 | 0 | 3.5 |
| 2025-09 | 0 | 1.67 |
| 2025-10 | 0 | 1.5 |
| 2025-11 | 0 | 3.25 |
| 2025-12 | 0 | 4.25 |
| 2026-02 | 0 | 3.06 |
| 2026-03 | 0 | 2.14 |
| 2026-04 | 0 | 2.59 |
| 2026-05 | 0 | 2.47 |
| 2026-06 | 0 | 4.82 |
Regulatory clearances
- K243443 SESE 2025-03-19 (k number procode)
Predicate lineage
K243443 — cites (transitively): K152172 (d1), K193017 (d1), K240243 (d1), K110033 (d2), K162552 (d2), K231225 (d2), K091364 (d3), K150766 (d3), K151942 (d3), K130464 (d4), K142475 (d4), K091090 (d5)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — DRTECH Corporation
- NAI 2019-01-17 DRTech Corp. · 0 citations
- NAI 2019-01-17 DRTech Corp. · 0 citations