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510(k) K050667

R2 FAMILY OF IMAGE DISPLAY UNITS WITH R2 UNIFORM DISPLAY SOFTWARE by R2 Technology, Inc. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2005
Date Received
March 15, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

Other clearances by R2 Technology, Inc.

  • K051743 — R2 BREAST IMAGING WORKSTATION (July 25, 2005)
  • K041380 — IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR (June 8, 2004)
  • K040028 — CA-1500 (January 22, 2004)
  • K023003 — IMAGECHECKER-CT WORKSTATION (November 20, 2002)

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