Atlas FDA

HGL

36 FDA 510(k) clearances · Product code

94 daysmedian time to decision
207 days90th percentile
36clearances measured

FDA profile

Official device name
Transducer, Ultrasonic, Obstetric
Device class
Class II (moderate risk)
Regulation
21 CFR 884.2960
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
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RecordFirmDate
ULTRASOUND TRANSDUCER, MODEL US917 (K952031)Advanced Medical Systems, Inc.1995-07-18
ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION (K923335)Advanced Medical Systems, Inc.1994-07-22
OP3/VP4 (K924516)Huntleigh Technology, Inc.1993-06-28
ULTRASONIC PULSED DOPPLER IMAGING SYSTEM (K903348)Advanced Technology Laboratories, Inc.1990-10-22
EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE (K900966)Hitachi Medical Corp. of America1990-09-12
ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER (K903316)Ge Medical Systems Information Technologies1990-08-22
MER MULTIPLANE VAGINAL PROBE (MVP) (K901142)Medical Equipment Resources1990-08-22
TRANSVAGINAL TRANSDUCER ASSEMBLY (K900838)Pie Medical Equipment B.V.1990-05-23
ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM (K895449)Ge Medical Systems Information Technologies1990-03-05
MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER (K881263)Multigon Industries, Inc.1990-01-05
5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER (K895647)Advanced Technology Laboratories, Inc.1989-12-18
5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER (K895123)Advanced Technology Laboratories, Inc.1989-11-13
HP MODEL M1318A TRANSVAGINAL ULTRASOUND TRANSDUCER (K895026)Hewlett-Packard Co.1989-11-06
DYMAX ENDOVAGINAL BIOPSY GUIDE (K894415)Dymax Corp1989-10-25
GENERAL IVT NEEDLE GUIDE KIT, STERILE (K892070)Amedic USA1989-09-05
SIEMENS INTRAVAGINAL TRANSDUCER (K881405)Siemens Medical Solutions USA, Inc.1988-08-02
KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM (K875334)Kontron Instruments, Inc.1988-03-24
KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM (K875371)Kontron Instruments, Inc.1988-03-24
ULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE. (K872265)Labsonics, Inc.1988-01-04
ANNULAR ARRAY SCANHEAD (K871856)Advanced Technology Laboratories, Inc.1987-08-28
TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE (K864219)Amedic USA1987-03-27
DIASONICS TRANSVAGINAL, TV 7.5 MHZ PROBE (K864908)Diasonics, Inc.1987-03-27
280SL IMAGING SYSTEM TRANVAGINAL PROBES (K864151)Ge Medical Systems Information Technologies1987-03-27
BIOPSY NEEDLE GUIDE ATTACHMENT (K863797)Elscint, Inc.1987-03-27
ACUSON TV519 TRANSDUCER (K864578)Acuson Computed Sonography1987-03-27
7.5 MHZ ENDOVAGINAL PROBE (K870709)Philips Ultrasound, Inc.1987-03-27
TRANSVAGINAL PROBE, MODEL ED65M-TV (K861371)Elscint, Inc.1986-07-14
FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01 (K862072)International Biomedics, Inc.1986-07-09
ACUSON S228, S519 & L558 TRANSDUCERS (K861577)Acuson Computed Sonography1986-06-19
ACUSON S328, L382, L538 & L312 TRANSDUCERS (K861578)Acuson Computed Sonography1986-06-17
TRANSVAGINAL TRANSDUCER, 5MHZ (K860234)Philips Medical Systems, Inc.1986-05-23
1MHZ CW DOPPLER TRANSDUCER W/LILY ANTEPARTUM #507 (K860621)Impex Medical Systems, Inc.1986-05-20
3.0 MHZ LINEAR ARRAY PROBE MODEL UST 5031 (K860313)Johnson & Johnson Professionals, Inc.1986-03-17
BIO-DERM COUPLING LOTION (K827885)Whs Products, Inc.1982-01-29
DIAG. ULTRASOUND B-SCANNER (K771869)Accusonics, Inc.1977-11-02
ARTIUS SYSTEM (K771151)General Electric Co.1977-08-04

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Every clearance here is in the API, with alerts when new ones post.