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510(k) K071193

VIDAR VISION 3000 AND 4000 X-RAY SYSTEMS by Vidar Systems Corp. — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2007
Date Received
April 30, 2007
Clearance Type
Special
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 Vidar Systems Corp.

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  • K102476 — TELERADPRO (October 7, 2010)
  • K093809 — VIDAR DENTAL FILM DIGITIZER (January 7, 2010)
  • K070563 — VIDAR VISION 2000 (March 16, 2007)
  • K024171 — VIDAR BONE TRACK SYSTEM SOFTWARE (March 4, 2003)
  • K011049 — EXPRESSSUITE (October 1, 2001)
  • K993598 — MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205 (January 20, 2000)
  • K993599 — DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMETRY PRO, MODEL 13 (January 18, 2000)
  • K993597 — PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619/9617 (December 15, 1999)

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)