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510(k) K904599

D2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMPUTER SYSTEM by Digital Design, Inc. — Product Code JWM

K904599 is an FDA 510(k) premarket notification submitted by Digital Design, Inc. for the device "D2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMPUTER SYSTEM". The FDA issued a decision of Substantially Equivalent on April 23, 1991. The device falls under product code JWM (System, Tomographic, Nuclear), a Class II device regulated under 21 CFR 892.1310.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1991
Date Received
October 10, 1990
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 for product code JWM

  • K914350 — ICON COMPUTER SYSTEM (November 22, 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)
  • K851686 — DIGITAL GAMMA CAMERA GCA 501S (June 5, 1985)
  • K851687 — JUMBO DIGITAL GAMMACAMERA GCA-90B (June 5, 1985)
  • K841905 — DOT-A, DOT-AR PXP-E, PXP-ER (August 9, 1984)

FDA data resources