Home / 510(k) Clearances / K874473

510(k) K874473

ADAC MODEL ARC-ST, PC STYLE DATA PROCESSING SYSTEM by Adac Laboratories — Product Code JWM

K874473 is an FDA 510(k) premarket notification submitted by Adac Laboratories for the device "ADAC MODEL ARC-ST, PC STYLE DATA PROCESSING SYSTEM". The FDA issued a decision of Substantially Equivalent on July 18, 1988. The device falls under product code JWM (System, Tomographic, Nuclear), a Class II device regulated under 21 CFR 892.1310. Adac Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1988
Date Received
November 2, 1987
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 Adac Laboratories

  • K062298 — APOLLO GAMMA CAMERA SYSTEM (August 23, 2006)
  • K061029 — JETSTREAM WORKSPACE (May 1, 2006)
  • K060020 — AUTOQUANT PLUS (January 20, 2006)
  • K051351 — PRECEDENCE SPECT/CT IMAGING SYSTEM (June 8, 2005)
  • K042880 — JETSTREAM WORKSPACE (November 3, 2004)
  • K042903 — AUTOSPECS (October 29, 2004)
  • K041577 — PINNACLE3 RADIATION THERAPY PLANNING SYSTEM (June 25, 2004)
  • K041218 — GRIFFIN SPECT/CT IMAGING SYSTEM (May 24, 2004)
  • K041182 — SYNTEGRA (May 21, 2004)
  • K040326 — AUTOQUANT PLUS (February 25, 2004)

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)
  • 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