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510(k) K903348

ULTRASONIC PULSED DOPPLER IMAGING SYSTEM by Advanced Technology Laboratories, Inc. — Product Code HGL

K903348 is an FDA 510(k) premarket notification submitted by Advanced Technology Laboratories, Inc. for the device "ULTRASONIC PULSED DOPPLER IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on October 22, 1990. The device falls under product code HGL (Transducer, Ultrasonic, Obstetric), a Class II device regulated under 21 CFR 884.2960. Advanced Technology Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1990
Date Received
July 26, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Obstetric
Device Class
Class II
Regulation Number
884.2960
Review Panel
OB
Submission Type

Other clearances by Advanced Technology Laboratories, Inc.

  • K021966 — Q LAB SOFTWARE (July 2, 2002)
  • K011224 — HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, A (May 4, 2001)
  • K002144 — MEDLINK DIAGNOSTIC OFFLINE WORKSTATION (September 28, 2000)
  • K992470 — ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM (August 23, 1999)
  • K991671 — HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM (June 18, 1999)
  • K961459 — LEVEL 10 HDI (March 26, 1997)
  • K935009 — PEGASUS (October 11, 1994)
  • K940423 — NOVA MICROSONICS ACCESS IMAGE MANAGEMENT NETWORK/ACCESS ACQUISITION MODULE (July 29, 1994)
  • K905248 — NOVA MICROSONICS CAPRICORN DIGITAL IMAGE SYSTEMS (February 28, 1991)
  • K903603 — ULTRAMARK 9 ULTRASOUND SYSTEM (UM 9) (February 26, 1991)

Other clearances for product code HGL

  • K952031 — ULTRASOUND TRANSDUCER, MODEL US917 (July 18, 1995)
  • K923335 — ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION (July 22, 1994)
  • K924516 — OP3/VP4 (June 28, 1993)
  • K900966 — EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE (September 12, 1990)
  • K903316 — ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER (August 22, 1990)
  • K901142 — MER MULTIPLANE VAGINAL PROBE (MVP) (August 22, 1990)
  • K900838 — TRANSVAGINAL TRANSDUCER ASSEMBLY (May 23, 1990)
  • K895449 — ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM (March 5, 1990)
  • K881263 — MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER (January 5, 1990)
  • K895647 — 5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER (December 18, 1989)

FDA data resources