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510(k) K954356

COMPAX 90/15E by General Electric Co. — Product Code IXR

K954356 is an FDA 510(k) premarket notification submitted by General Electric Co. for the device "COMPAX 90/15E". The FDA issued a decision of Substantially Equivalent on October 7, 1995. The device falls under product code IXR (Table, Radiographic, Tilting), a Class II device regulated under 21 CFR 892.1980. General Electric Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 1995
Date Received
September 18, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Radiographic, Tilting
Device Class
Class II
Regulation Number
892.1980
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 IXR

  • K000412 — VISION R/F TILTING TABLE (April 24, 2000)
  • K973039 — LEGACY/LEGACY-D TABLE (October 16, 1997)
  • K971128 — CAP-35B III/CINE 275 (April 28, 1997)
  • K970640 — PHILIPS EASY DIAGNOST (March 21, 1997)
  • K965105 — ELECTROPHYSIOLOGY TILT TABLE MODEL #9660 (January 30, 1997)
  • K965096 — FLUOROVIEW SERIES FLUOROSCOPIC TABLES (January 27, 1997)
  • K963851 — TILTING RADIOGRAPHIC TABLE (REMOTE) (January 23, 1997)
  • K961022 — TANGENT VI TABLE (May 3, 1996)
  • K953557 — SURGICAL C-ARM TABLE, 9610 (September 26, 1995)
  • K953556 — VACS TABLE, 9650 (September 26, 1995)

FDA data resources