Home / 510(k) Clearances / K051765

510(k) K051765

CERETOM, MODEL NL3000 by Neurologica Corporation — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2005
Date Received
June 30, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Neurologica Corporation

  • K250928 — OmniTom Elite with PCD (September 8, 2025)
  • K233767 — OmniTom Elite (June 10, 2024)
  • K213649 — BodyTom 64 (April 29, 2022)
  • K171183 — OmniTom (August 18, 2017)
  • K142697 — NExCT 7 (December 23, 2014)
  • K102677 — BODYTOM NL 4000 (March 24, 2011)
  • K090811 — INSPIRA HD, MODEL: NL1000 (August 27, 2009)

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)