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510(k) K210919

AcuityDRe by Radmedix, LLC — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2021
Date Received
March 29, 2021
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 Radmedix, LLC

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  • K201058 — Accuvue+ (May 6, 2020)
  • K200726 — AcuityPDR (April 13, 2020)
  • K193360 — Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard (January 2, 2020)

Other clearances for product code MQB

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  • 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)