PHOENIX— 510(k) K212291

Name: FDA 510(k) clearance K212291
Creator: U.S. Food and Drug Administration
Published: 2021-09-14

Substantially Equivalent

Sedecal., Sa.

FDA 510(k) clearance K212291 for PHOENIX, Substantially Equivalent on 2021-09-14. Applicant: Sedecal., Sa.. Device class: 2.

Clearance details

Applicant: Sedecal., Sa.
Product code: Code IZL
Device class: Class 2
Regulation: 21 CFR 892.1720
Advisory panel: Radiology
Date received: 2021-07-22
Decision date: 2021-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Algete, ES

Download summary PDF View on FDA.gov ↗

Recent devices under product code IZL

view all

K260236 — XLITE2026-08-03
K253058 — Portable DR Imaging System2026-06-18
K260085 — RAYMO Mobile X-ray System (Model: RAYMO)2026-05-14
K253185 — Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System2026-03-11
K253244 — AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)2026-02-23

More clearances from Sedecal., Sa.

view all

K232185 — SM-IV2023-08-21
K222951 — SM-V2022-11-21
K221803 — PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.2022-07-18
K203537 — Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems2021-02-01
K202293 — Radiographic System Challenge X2020-10-07

Adverse events under product code IZL

product code IZL

Other: 3
Total: 3

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 →

Recalls naming K212291

K-number listed on FDA's recall record

Z-1202-2023 — Phoenix mKDR, digital mobile diagnostic x-ray systemClass II·Ongoing·SEDECAL SA·20230206

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K212291.

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