JOP · Class II · 21 CFR 870.2880

FDA Product Code JOP: Transducer, Ultrasonic

Leading manufacturers include Advanced Technology Laboratories, Inc., Acuson Computed Sonography and Johnson & Johnson Professionals, Inc..

72
Total
72
Cleared
165d
Avg days
1981
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg 105d recently vs 166d historically

FDA 510(k) Cleared Transducer, Ultrasonic Devices (Product Code JOP)

72 devices
1–24 of 72
Cleared Dec 18, 2024
Falcon/Xpress (Falcon/Xpress)
K242662
Viasonix , Ltd.
Cardiovascular · 105d
Cleared Jul 19, 2024
VasoGuard (V10, V8, V6, V4, V2)
K233976
Corvascular Diagnostics, LLC
Cardiovascular · 217d
Cleared May 25, 2016
Smartdop XT6
K153762
Koven Technology, Inc.
Cardiovascular · 147d
Cleared Jan 17, 2014
SMARTDOP XT
K131623
Koven Technology, Inc.
Cardiovascular · 227d
Cleared Sep 27, 2013
VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING
K131860
Us Vascular, LLC
Cardiovascular · 95d
Cleared Jul 15, 2011
FALCON
K111416
Viasonix , Ltd.
Radiology · 56d
Cleared Sep 16, 1999
ECHOFLOW DOPPLER BLOOD VELOCITY METER
K990642
Echocath, Inc.
Cardiovascular · 202d
Cleared May 13, 1994
REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8
K934638
Koven Technology, Inc.
Cardiovascular · 231d
Cleared Feb 11, 1991
UST-2266U-5 CW DOPPLER TRANSDUCER
K905369
Ge Medical Systems Information Technologies
Cardiovascular · 74d
Cleared Jan 24, 1990
MILLAR MIKRO-TIP DOPPLER CATHETER
K896264
Millar Instruments, Inc.
Cardiovascular · 85d
Cleared Aug 07, 1989
CARDIAC COMPUTATION SOFTWARE PACKAGE
K890636
Elscint, Inc.
Cardiovascular · 180d
Cleared Aug 07, 1989
VOLUME COMPUTATION SOFTWARE PACKAGE
K890638
Elscint, Inc.
Cardiovascular · 180d
Cleared Jul 19, 1989
INTERSPEC TRANSESOPHAGEAL PROBE MODEL 4515
K892944
Interspec, Inc.
Cardiovascular · 89d
Cleared Jun 12, 1989
RESUBMITTAL OF MI 1000C MICROIMAGER
K881979
Ausonics Pty , Ltd.
Cardiovascular · 396d
Cleared Nov 29, 1988
TRANSESOPHAGEAL ECHO TRANSDUCER
K883889
General Electric Co.
Cardiovascular · 76d
Cleared Oct 07, 1988
SDU-700 PHASED ARRAY SECTOR AND LINEAR SCANNER
K873674
Shimadzu Corp.
Cardiovascular · 392d
Cleared Aug 12, 1988
GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER
K881723
Biosound, Inc.
Cardiovascular · 113d
Cleared May 20, 1988
BIOSOUND MMI ULTRASOUND
K871442
Biosound, Inc.
Cardiovascular · 403d
Cleared Oct 20, 1987
RT5000 ECHOCARDIOGRAPHY #H4100C/CE
K870726
General Electric Co.
Cardiovascular · 238d
Cleared Sep 28, 1987
AUXILIARY CONTINUOUS WAVE DOPPLER TRANSDUCER
K871416
Acuson Computed Sonography
Cardiovascular · 174d
Cleared Sep 28, 1987
ACUSON L538 TRANSDUCER
K871506
Acuson Computed Sonography
Cardiovascular · 164d
Cleared Aug 25, 1987
5 MHZ TRANSDUCER
K872074
Sonicaid, Inc.
Cardiovascular · 88d
Cleared Aug 14, 1987
MASCOT CW DOPPLER SYSTEM
K871212
Imex Medical Systems, Inc.
Cardiovascular · 141d
Cleared Aug 10, 1987
SSD-725 ULTRASOUND SECTOR SCANNER
K870607
Ge Medical Systems Information Technologies
Cardiovascular · 180d

About Product Code JOP - Regulatory Context

510(k) Submission Activity

72 total 510(k) submissions under product code JOP since 1981, with 72 receiving FDA clearance (average review time: 165 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - JOP Product Code

Recent submissions under JOP have taken an average of 105 days to reach a decision - down from 166 days historically, suggesting improved FDA processing for this classification.

JOP devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →