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510(k) K111304

OPTIMA XR120 by Ge Medical Systems, LLC — Product Code IXL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2011
Date Received
May 9, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Spot-Film
Device Class
Class II
Regulation Number
892.1670
Review Panel
RA
Submission Type

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Other clearances for product code IXL

  • K964806 — MD-1835 (March 4, 1997)
  • K950317 — ADVANTX 1824 SPOTFILM DEVICE (February 8, 1995)
  • K940386 — KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LP (August 17, 1994)
  • K942367 — AXT 1400 SPOTFILM DEVICE (June 6, 1994)
  • K924593 — DIAGNOST 76 FAMILY*R/F SYSTEMS - RELEASE 4.4 (November 24, 1992)
  • K902403 — ELITE R/F SPOT FILM DRIVE (August 1, 1990)
  • K902146 — SFD-035 SPOT FILM DEVICE (May 31, 1990)
  • K882492 — A.X.T. SPOTFILM DEVICE (July 21, 1988)
  • K881589 — 14X14 MULTIFORMAT SPOT FILMER, NO. 6650.400 (July 18, 1988)
  • K842184 — SPOT-FILM DEVICE 8835 (July 17, 1984)