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510(k) K770783

FILM PROCESSOR, AUTOMATIC by General Electric Co. — Product Code EGY

K770783 is an FDA 510(k) premarket notification submitted by General Electric Co. for the device "FILM PROCESSOR, AUTOMATIC". The FDA issued a decision of Substantially Equivalent on May 10, 1977. The device falls under product code EGY (Processor, Radiographic-Film, Automatic, Dental), a Class II device regulated under 21 CFR 892.1900. General Electric Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 1977
Date Received
May 2, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Processor, Radiographic-Film, Automatic, Dental
Device Class
Class II
Regulation Number
892.1900
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 EGY

  • K992896 — DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, 830) (September 3, 1999)
  • K955825 — SMITH S-100 TIME & TEMPERATURE CONTROL (April 5, 1996)
  • K955643 — ALARA IMAGING SYSTEM (March 1, 1996)
  • K945682 — PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL (February 9, 1995)
  • K900156 — AP201 DENTAL X-RAY FILM PROCESSOR (May 14, 1990)
  • K874118 — MODEL 410 DENTAL X-RAY FILM PROCESSORS (November 6, 1987)
  • K811211 — YOSHIDA AP 100 (June 16, 1981)
  • K771433 — AUTO. DEVEL. UNIT FOO DENTAL X-RAY (August 19, 1977)

FDA data resources