Home / 510(k) Clearances / K851902

510(k) K851902

MODEL U-1000 ULTRASONIC SCANNER by Fukuda Denshi USA, Inc. — Product Code HEM

K851902 is an FDA 510(k) premarket notification submitted by Fukuda Denshi USA, Inc. for the device "MODEL U-1000 ULTRASONIC SCANNER". The FDA issued a decision of Substantially Equivalent on September 27, 1985. The device falls under product code HEM (Imager, Ultrasonic Obstetric-Gynecologic), a Class II device regulated under 21 CFR 884.2225. Fukuda Denshi USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1985
Date Received
April 30, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Imager, Ultrasonic Obstetric-Gynecologic
Device Class
Class II
Regulation Number
884.2225
Review Panel
OB
Submission Type

Other clearances by Fukuda Denshi USA, Inc.

  • K173226 — CardiMax Electrocardiograph (April 16, 2018)
  • K150030 — Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor (March 16, 2015)
  • K134046 — FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR (February 12, 2015)
  • K112521 — FUKUDA DENSHI VASERA MODEL VS-1500 (December 21, 2011)
  • K103134 — FUKUDA DENSHI (March 11, 2011)
  • K083697 — FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//700 (March 19, 2009)
  • K082656 — MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT (September 30, 2008)
  • K081891 — FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR (August 29, 2008)
  • K050363 — FUKUDA DENSHI MODEL UF-850XTD (February 17, 2005)
  • K033711 — FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM (June 3, 2004)

Other clearances for product code HEM

  • K951393 — ABACUS OB ULTRASOUNG COMPUTER SOFTWARE (May 1, 1995)
  • K942490 — BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND (February 15, 1995)
  • K910426 — SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT (June 6, 1991)
  • K905000 — ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER (January 31, 1991)
  • K900505 — SONOACE 88 PORTABLE ULTRASOUND SCANNER (August 10, 1990)
  • K900271 — MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK (April 19, 1990)
  • K890637 — EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE (June 12, 1989)
  • K881329 — FETAL DOPPLER FOR ULTRAMARK 4 AND 8 (April 14, 1989)
  • K885061 — SIEMENS INTRAVAGINAL TRANSDUCER (February 23, 1989)
  • K880900 — SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER (June 1, 1988)

FDA data resources