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510(k) K951393

ABACUS OB ULTRASOUNG COMPUTER SOFTWARE by Solomon Technology Labs — Product Code HEM

K951393 is an FDA 510(k) premarket notification submitted by Solomon Technology Labs for the device "ABACUS OB ULTRASOUNG COMPUTER SOFTWARE". The FDA issued a decision of Substantially Equivalent on May 1, 1995. The device falls under product code HEM (Imager, Ultrasonic Obstetric-Gynecologic), a Class II device regulated under 21 CFR 884.2225.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1995
Date Received
March 27, 1995
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 for product code HEM

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

FDA data resources