Home / 510(k) Clearances / K780769

510(k) K780769

S-100 CT SCANNER by Syntex Corp. — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1978
Date Received
May 5, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

Other clearances by Syntex Corp.

  • K920314 — TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION) (April 17, 1992)
  • K843593 — SURGIPRESS SURGICAL LOOP (October 24, 1984)
  • K780997 — AMALGAM ALLOY (July 27, 1978)
  • K780483 — FIBER OPTIC HANDPIECE (April 28, 1978)
  • K761331 — OPUS I OPTION - FIBER OPTIC L SYSTEM (January 3, 1977)
  • K761330 — SYNTEX SYSTEM 6000 (December 30, 1976)
  • K761332 — HI-SENSITIVITY MODE OPTION FOR S60-1A (December 30, 1976)
  • K761264 — OPTIONS FOR STAR DENTAL OPUS I (December 23, 1976)
  • K761033 — COMPUTERIZED TOMOGRAPHY SCANNER (November 24, 1976)

Other clearances for product code JAK

  • K260078 — Aquilion ServeSP (TSX-307B) V2.0 (March 13, 2026)
  • K252249 — Extremity CT Imaging System (March 13, 2026)
  • K260167 — Bunkerhill Contrast AVC (March 6, 2026)
  • K260166 — Bunkerhill Contrast CAC (March 6, 2026)
  • K260169 — AV Cardiac CT (March 5, 2026)
  • K253173 — uCT 780 with uWS-CT-Dual Energy Analysis (January 20, 2026)
  • K252217 — CT VScore+ (November 28, 2025)
  • K251805 — syngo.CT Dual Energy (October 15, 2025)
  • K250662 — Bunkerhill MAC (October 3, 2025)
  • K250766 — LungQ 4 (October 2, 2025)