Hand Diagnostic Radiography Imaging System— 510(k) K220271

Name: FDA 510(k) clearance K220271
Creator: U.S. Food and Drug Administration
Published: 2022-04-29

Substantially Equivalent

Nanoray Biotech Co., Ltd.

FDA 510(k) clearance K220271 for Hand Diagnostic Radiography Imaging System, Substantially Equivalent on 2022-04-29. Applicant: Nanoray Biotech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Nanoray Biotech Co., Ltd.
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2022-01-31
Decision date: 2022-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei City, TW

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

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.