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510(k) K013897

SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW by Bio-Scan S.A — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2002
Date Received
November 23, 2001
Clearance Type
Abbreviated
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 Bio-Scan S.A

  • K003480 — BIOFIND (May 11, 2001)
  • K925735 — EEG ANALYZER (December 3, 1993)
  • K864928 — BIO-LOG 8+1 AMBULATORY PHYSIOLOGIC RECORDER (March 31, 1987)
  • K841684 — BIO/SCAN BIOLOG CASSETTE RECORDER (June 7, 1984)
  • K841683 — Q.P. PREAMPLIFIER SYS (June 7, 1984)
  • K841685 — EEG ELECTRODES (June 7, 1984)

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