Transducer, Ultrasonic, Obstetric

Product Code: HGL

Obstetrics/Gynecology Diagnostic Ultrasound Devices

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 884.2960


Radiation TypeAcoustic
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as HGL

3952Transducer, Ultrasonic, ObstetricObstetric Ultrasonic Transducer And Accessories.

Total Product Life Cycle (TPLC) Devices

3952Transducer, Ultrasonic, ObstetricObstetric Ultrasonic Transducer And Accessories.

Pre-market Notifications for HGL

K952031ULTRASOUND TRANSDUCER, MODEL US917ADVANTAGE MEDICAL SYSTEMS, INC.
K924516OP3/VP4HUNTLEIGH TECHNOLOGY, INC.
K923335ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATIONADVANTAGE MEDICAL SYSTEMS, INC.
K903348ULTRASONIC PULSED DOPPLER IMAGING SYSTEMADVANCED TECHNOLOGY LABORATORIES, INC.
K903316ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCERGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K901142MER MULTIPLANE VAGINAL PROBE (MVP)MEDICAL EQUIPMENT RESOURCES
K900966EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBEHITACHI MEDICAL CORP. OF AMERICA
K900838TRANSVAGINAL TRANSDUCER ASSEMBLYPIE MEDICAL EQUIPMENT B.V.
K8956475.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCERADVANCED TECHNOLOGY LABORATORIES, INC.
K895449ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEMGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K8951235.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCERADVANCED TECHNOLOGY LABORATORIES, INC.
K895026HP MODEL M1318A TRANSVAGINAL ULTRASOUND TRANSDUCERHEWLETT-PACKARD CO.
K894415DYMAX ENDOVAGINAL BIOPSY GUIDEDYMAX CORP.
K892070GENERAL IVT NEEDLE GUIDE KIT, STERILEAMEDIC USA
K881263MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLERMULTIGON INDUSTRIES, INC.

Global Unique Device Identification Database

00816787023459TRANSDUCER, ULTRASONIC, OBSTETRIC
00816787023442TRANSDUCER, ULTRASONIC, OBSTETRIC
00816787023435TRANSDUCER, ULTRASONIC, OBSTETRIC
00816787023428TRANSDUCER, ULTRASONIC, OBSTETRIC
00816787023411TRANSDUCER, ULTRASONIC, OBSTETRIC
00816787023398TRANSDUCER, ULTRASONIC, OBSTETRIC
00816787023381TRANSDUCER, ULTRASONIC, OBSTETRIC
00816787023374TRANSDUCER, ULTRASONIC, OBSTETRIC
00816787023367TRANSDUCER, ULTRASONIC, OBSTETRIC
00816787023350TRANSDUCER, ULTRASONIC, OBSTETRIC
00816787023343TRANSDUCER, ULTRASONIC, OBSTETRIC
00816787023336TRANSDUCER, ULTRASONIC, OBSTETRIC
00816787023329TRANSDUCER, ULTRASONIC, OBSTETRIC
00816787023312TRANSDUCER, ULTRASONIC, OBSTETRIC
00816787023305TRANSDUCER, ULTRASONIC, OBSTETRIC

Maude Adverse Events

FETAL MONITOR/CARDIOTOCOGRAMBISTOS CO., LTD.2018-01-29
FETAL MONITOR/CARDIOTOCOGRAMBISTOS CO., LTD.2018-01-29
FETAL MONITORBISTOS CO., LTD.2018-01-29
FETAL MONITORBISTOS CO., LTD.2018-01-29
FETAL MONITOR/CARDIOTOCOGRAMBISTOS CO., LTD.2018-01-29
FETAL MONITORBISTOS CO., LTD.2018-01-29

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