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510(k) K244010

ExamVue Apex by Jpi Healthcare Co, Ltd. — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2025
Date Received
December 26, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

Other clearances by Jpi Healthcare Co, Ltd.

  • K213057 — ExamVue Duo (February 18, 2022)
  • K142930 — Exam Vue DR (April 17, 2015)
  • K102327 — CLEARVISION DR 7000F (April 13, 2012)
  • K101779 — CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM (May 16, 2011)
  • K955706 — JPI AUTOMATIC X-RAY FILM PROCESSOR (February 12, 1996)
  • K954161 — JPI INTENSIFYING SCREEN (February 2, 1996)
  • K950043 — JPI AUTOMATIC X-RAY FILM PROCESSOR (May 10, 1995)

Other clearances for product code MQB

  • K252911 — Lux HD 2530 detector (Lux HD 2530) (October 9, 2025)
  • K250211 — Yushan X-Ray Flat Panel Detector (July 22, 2025)
  • K250665 — SKR 3000 (June 17, 2025)
  • K243734 — Wireless/ Wired X-Ray Flat Panel Detectors (April 18, 2025)
  • K242770 — EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG (March 20, 2025)
  • K243443 — EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXP (March 19, 2025)
  • K243556 — Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) (March 18, 2025)
  • K243171 — Yushan X-Ray Flat Panel Detector (December 19, 2024)
  • K241319 — SKR 3000 (November 21, 2024)
  • K241125 — VIVIX-S 1751S (November 15, 2024)