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510(k) K842184

SPOT-FILM DEVICE 8835 by General Electric Co. — Product Code IXL

K842184 is an FDA 510(k) premarket notification submitted by General Electric Co. for the device "SPOT-FILM DEVICE 8835". The FDA issued a decision of Substantially Equivalent on July 17, 1984. The device falls under product code IXL (Device, Spot-Film), a Class II device regulated under 21 CFR 892.1670. General Electric Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1984
Date Received
June 1, 1984
Clearance Type
Traditional
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

Other clearances by General Electric Co.

  • K110798 — SENOGRAPHE DS, SENOGRAPHE ESSENTIAL (December 22, 2011)
  • K103485 — SENOGRAPH DS, SENOGRAPH ESSENSTIAL (October 6, 2011)
  • K103489 — GE VEO RECONSTRUCTION OPTION (September 9, 2011)
  • K082317 — GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION (September 26, 2008)
  • K081921 — GE VIVID E9 ULTRASOUND (August 6, 2008)
  • K073297 — GE LOGIQ P6 (December 18, 2007)
  • K072952 — GE ECHOPAC (November 16, 2007)
  • K072797 — GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPAC (October 17, 2007)
  • K072075 — MODIFICATION TO GE LOGIQ A3 (August 29, 2007)
  • K071985 — GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND (August 17, 2007)

Other clearances for product code IXL

  • K111304 — OPTIMA XR120 (July 19, 2011)
  • 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)

FDA data resources