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510(k) K974432

ULTRAGUIDE 1000 by Ultraguide , Ltd. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1998
Date Received
November 24, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

Other clearances by Ultraguide , Ltd.

  • K023227 — USG 2000SA (October 22, 2002)
  • K022354 — ULTRAGUIDE CTG 2000SA (August 13, 2002)
  • K013150 — MR-GUIDE 2000 (October 18, 2001)
  • K011418 — ULTRAGUIDE MR-GUIDE 3000 (May 24, 2001)
  • K002258 — ULTRAGUIDE CT-GUIDE 1010 (August 8, 2000)

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  • K253714 — IntraSight Plus (February 24, 2026)
  • K253221 — Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) (February 6, 2026)
  • K250331 — Astrasono A3Pro Bladder Scanner (A3Pro) (September 30, 2025)
  • K250381 — Deepsight NeedleVue LC1 Ultrasound System (August 1, 2025)
  • K243227 — B-Scan (July 11, 2025)
  • K251728 — Velacur One (LI-1100) (June 26, 2025)