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510(k) K910426

SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT by Shimadzu Medical Systems — Product Code HEM

K910426 is an FDA 510(k) premarket notification submitted by Shimadzu Medical Systems for the device "SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT". The FDA issued a decision of Substantially Equivalent on June 6, 1991. The device falls under product code HEM (Imager, Ultrasonic Obstetric-Gynecologic), a Class II device regulated under 21 CFR 884.2225. Shimadzu Medical Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1991
Date Received
January 30, 1991
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 Shimadzu Medical Systems

  • K082224 — DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC (December 15, 2008)
  • K071291 — ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 (January 9, 2008)
  • K071287 — ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO (January 9, 2008)
  • K071289 — ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO (January 9, 2008)
  • K061643 — ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO (July 27, 2006)
  • K061637 — ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO (July 25, 2006)
  • K061641 — ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO (July 14, 2006)
  • K052500 — DAR-8000F (October 17, 2005)
  • K052076 — DAR-8000I (September 2, 2005)
  • K050510 — ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 (April 1, 2005)

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)
  • 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)
  • K881185 — ANNULAR ARRAY PROBES FOR ARTIS 3200 DIAG. ULTRA. (June 1, 1988)

FDA data resources