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510(k) K801917

STAR by General Electric Co. — Product Code JWM

K801917 is an FDA 510(k) premarket notification submitted by General Electric Co. for the device "STAR". The FDA issued a decision of Substantially Equivalent on September 16, 1980. The device falls under product code JWM (System, Tomographic, Nuclear), a Class II device regulated under 21 CFR 892.1310. General Electric Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1980
Date Received
August 11, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Tomographic, Nuclear
Device Class
Class II
Regulation Number
892.1310
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 JWM

  • K914350 — ICON COMPUTER SYSTEM (November 22, 1991)
  • K904599 — D2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMPUTER SYSTEM (April 23, 1991)
  • K903315 — ICON (January 9, 1991)
  • K901545 — GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM (June 26, 1990)
  • K874473 — ADAC MODEL ARC-ST, PC STYLE DATA PROCESSING SYSTEM (July 18, 1988)
  • K873075 — ADAC MODEL ARC-5000, GAMMA CAMERA (October 30, 1987)
  • K851685 — DIGITAL GAMMA CAMERA GCA 601 E (June 14, 1985)
  • K850885 — STARCAM DATA ACQUISITION & PROCESSING SYS H3300C (June 6, 1985)
  • K851687 — JUMBO DIGITAL GAMMACAMERA GCA-90B (June 5, 1985)
  • K851686 — DIGITAL GAMMA CAMERA GCA 501S (June 5, 1985)

FDA data resources