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510(k) K250665

SKR 3000 by Konica Minolta, Inc. — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2025
Date Received
March 5, 2025
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 Konica Minolta, Inc.

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  • K240281 — Bone Suppression Software (May 31, 2024)
  • K230906 — Konicaminolta DI-X1 (April 25, 2023)
  • K223267 — SKR 3000 (November 17, 2022)
  • K220993 — Ultrasound System SONIMAGE MX1 (June 23, 2022)
  • K213908 — SKR 3000 (January 31, 2022)
  • K212685 — KONICAMINOLTA DI-X1 (September 13, 2021)
  • K210619 — SKR 3000 (August 24, 2021)
  • K210066 — ImagePilot (May 6, 2021)
  • K191645 — SKR 4000 (August 16, 2019)

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)
  • 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)
  • K244010 — ExamVue Apex (February 24, 2025)
  • K243171 — Yushan X-Ray Flat Panel Detector (December 19, 2024)
  • K241319 — SKR 3000 (November 21, 2024)
  • K241125 — VIVIX-S 1751S (November 15, 2024)