Transducer, Ultrasonic, Obstetric
FDA product code HGL · Class II (moderate risk) · 21 CFR 884.2960 · Obstetrics/Gynecology
36510(k) clearances
0PMA approvals
4recalls
Manufacturers
- Advanced Technology Laboratories, Inc. 4
- Ge Medical Systems Information Technologies 3
- Acuson Computed Sonography 3
- Amedic USA 2
- Advanced Medical Systems, Inc. 2
- Kontron Instruments, Inc. 2
- Elscint, Inc. 2
- International Biomedics, Inc. 1
- Philips Medical Systems 1
- Impex Medical Systems, Inc. 1
- General Electric Co. 1
- Diasonics, Inc. 1
- Philips Ultrasound, Inc 1
- Johnson & Johnson Professionals, Inc. 1
- Labsonics, Inc. 1
- Whs Products, Inc. 1
- Siemens Medical Solutions USA, Inc. 1
- Dymax Corp 1
- Hewlett-Packard Co. 1
- Multigon Industries, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K952031 | Ultrasound Transducer, Model US917HGL · Traditional | Advanced Medical Systems, Inc. | 07/18/1995SE |
| K923335 | Ultrasound Transucer, Model US915 -- ModificationHGL · Traditional | Advanced Medical Systems, Inc. | 07/22/1994SE |
| K924516 | OP3/VP4HGL · Traditional | Huntleigh Technology, Inc. | 06/28/1993SE |
| K903348 | Ultrasonic Pulsed Doppler Imaging SystemHGL · Traditional | Advanced Technology Laboratories, Inc. | 10/22/1990SE |
| K900966 | EUP-V12 5.0 MHZ Convex Array Transvaginal ProbeHGL · Traditional | Hitachi Medical Corp. of America | 09/12/1990SE |
| K903316 | Aloka UST-964P-5 Endovaginal TransducerHGL · Traditional | Ge Medical Systems Information Technologies | 08/22/1990SE |
| K901142 | Mer Multiplane Vaginal Probe (MVP)HGL · Traditional | Medical Equipment Resources | 08/22/1990SE |
| K900838 | Transvaginal Transducer AssemblyHGL · Traditional | Pie Medical Equipment B.V. | 05/23/1990SE |
| K895449 | Aloka Model SSD-650 Ultrasound Imaging SystemHGL · Traditional | Ge Medical Systems Information Technologies | 03/05/1990SE |
| K881263 | Model 500A Vascular Spectrum Analyzer W/DopplerHGL · Traditional | Multigon Industries, Inc. | 01/05/1990SE |
| K895647 | 5.0 MHZ Convex Array Intravaginal TransducerHGL · Traditional | Advanced Technology Laboratories, Inc. | 12/18/1989SE |
| K895123 | 5.0 MHZ Convex Array Intravaginal TransducerHGL · Traditional | Advanced Technology Laboratories, Inc. | 11/13/1989SE |
| K895026 | HP Model M1318A Transvaginal Ultrasound TransducerHGL · Traditional | Hewlett-Packard Co. | 11/06/1989SE |
| K894415 | Dymax Endovaginal Biopsy GuideHGL · Traditional | Dymax Corp | 10/25/1989SE |
| K892070 | General Ivt Needle Guide Kit, SterileHGL · Traditional | Amedic USA | 09/05/1989SE |
| K881405 | Siemens Intravaginal TransducerHGL · Traditional | Siemens Medical Solutions USA, Inc. | 08/02/1988SE |
| K875371 | Kontron Sigma 1 Digital Echocardiograph SystemHGL · Traditional | Kontron Instruments, Inc. | 03/24/1988SE |
| K875334 | Kontron Sigma 1 Digital Echocardiograph SystemHGL · Traditional | Kontron Instruments, Inc. | 03/24/1988SE |
| K872265 | Ultrasound Breast Scanner W/Changes in Trans/Rece.HGL · Traditional | Labsonics, Inc. | 01/04/1988SE |
| K871856 | Annular Array ScanheadHGL · Traditional | Advanced Technology Laboratories, Inc. | 08/28/1987SN |
| K870709 | 7.5 MHZ Endovaginal ProbeHGL · Traditional | Philips Ultrasound, Inc. | 03/27/1987SE |
| K864908 | Diasonics Transvaginal, TV 7.5 MHZ ProbeHGL · Traditional | Diasonics, Inc. | 03/27/1987SE |
| K864578 | Acuson TV519 TransducerHGL · Traditional | Acuson Computed Sonography | 03/27/1987SE |
| K864219 | Transvaginal Ultrasound Biopsy Needle GuideHGL · Traditional | Amedic USA | 03/27/1987SE |
| K864151 | 280SL Imaging System Tranvaginal ProbesHGL · Traditional | Ge Medical Systems Information Technologies | 03/27/1987SE |
| K863797 | Biopsy Needle Guide AttachmentHGL · Traditional | Elscint, Inc. | 03/27/1987SE |
| K861371 | Transvaginal Probe, Model ED65M-TVHGL · Traditional | Elscint, Inc. | 07/14/1986SE |
| K862072 | Fetascan Ultrasound Transducer Ibi# 101B00054-01HGL · Traditional | International Biomedics, Inc. | 07/09/1986SE |
| K861577 | Acuson S228, S519 & L558 TransducersHGL · Traditional | Acuson Computed Sonography | 06/19/1986SE |
| K861578 | Acuson S328, L382, L538 & L312 TransducersHGL · Traditional | Acuson Computed Sonography | 06/17/1986SE |
| K860234 | Transvaginal Transducer, 5MHZHGL · Traditional | Philips Medical Systems, Inc. | 05/23/1986SE |
| K860621 | 1MHZ CW Doppler Transducer W/Lily Antepartum #507HGL · Traditional | Impex Medical Systems, Inc. | 05/20/1986SE |
| K860313 | 3.0 MHZ Linear Array Probe Model Ust 5031HGL · Traditional | Johnson & Johnson Professionals, Inc. | 03/17/1986SE |
| K827885 | Bio-Derm Coupling LotionHGL · Traditional | Whs Products, Inc. | 01/29/1982SE |
| K771869 | Diag. Ultrasound B-ScannerHGL · Traditional | Accusonics, Inc. | 11/02/1977SE |
| K771151 | Artius SystemHGL · Traditional | General Electric Co. | 08/04/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1167-2020 Class II | Ultrasound Transducer (M2736A), that may have been serviced with the following: Pacific…Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components… | Pacific Medical Group Inc. | 09/11/2019Open, Classified |
| Z-1164-2020 Class II | Ultrasound Transducer (M1356A), that may have been serviced with the following: Pacific…Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components… | Pacific Medical Group Inc. | 09/11/2019Open, Classified |
| Z-1162-2020 Class II | Loop-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700LAX, that may have been…Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components… | Pacific Medical Group Inc. | 09/11/2019Open, Classified |
| Z-1161-2020 Class II | Button-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700HAX, that may have been…Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components… | Pacific Medical Group Inc. | 09/11/2019Open, Classified |