SUINSA DIAGNOSTIC X-RAY SYSTEM— 510(k) K083109

Name: FDA 510(k) clearance K083109
Creator: U.S. Food and Drug Administration
Published: 2008-12-04

Substantially Equivalent

Suinsa

FDA 510(k) clearance K083109 for SUINSA DIAGNOSTIC X-RAY SYSTEM, Substantially Equivalent on 2008-12-04. Applicant: Suinsa. Device class: 2.

Clearance details

Applicant: Suinsa
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2008-10-20
Decision date: 2008-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Field, IL, US

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.