Radiographic System Challenge X— 510(k) K202293

Name: FDA 510(k) clearance K202293
Creator: U.S. Food and Drug Administration
Published: 2020-10-07

Substantially Equivalent

Sedecal., Sa.

FDA 510(k) clearance K202293 for Radiographic System Challenge X, Substantially Equivalent on 2020-10-07. Applicant: Sedecal., Sa.. Device class: 2.

Clearance details

Applicant: Sedecal., Sa.
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2020-08-13
Decision date: 2020-10-07
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Algete, ES

Download summary PDF View on FDA.gov ↗

Recent devices under product code KPR

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K260227 — EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H2026-09-08
K260488 — MULTIX Impact; MULTIX Impact C2026-08-31
K260481 — GC85A2026-08-27
K260482 — DRE Duo2026-06-15
K253446 — AeroDR TX c022026-04-10

More clearances from Sedecal., Sa.

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K232185 — SM-IV2023-08-21
K222951 — SM-V2022-11-21
K221803 — PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.2022-07-18
K212291 — PHOENIX2021-09-14
K203537 — Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems2021-02-01

Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.