K243443

EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP

510(k) number: K243443
Device name: EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP
Applicant: DRTECH Corporation KR
Product code: MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
Decision date: 2025-03-19
Date received: 2024-11-06
Decision: Substantially Equivalent
Clearance type: Special
Advisory committee: Radiology

Also available from FDA: K243443.pdf

Official FDA record: K243443

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.