Exprimer
Model EVS 3643W · DRTECH Corporation · DI 08800018406007
MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager) · Class II · 21 CFR 892.1680
UDILibrary device dossier · generated 2026-09-07 · 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
- K193017 SESE 2019-11-22 (k number procode)
Predicate lineage
K193017 — cites (transitively): K152172 (d1), K162552 (d1), K110033 (d2), K150766 (d2), K151942 (d2), K091364 (d3), K130464 (d3), K142475 (d3), K091090 (d4) — cited as predicate by K200726, K201058, K203703, K210919, K221081, K233530, K242847, K243443
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