JOP · Class II · 21 CFR 870.2880

FDA Product Code JOP: Transducer, Ultrasonic

Leading manufacturers include Advanced Technology Laboratories, Inc., Johnson & Johnson Professionals, Inc. and Ge Medical Systems Information Technologies.

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 Feb 11, 1991
UST-2266U-5 CW DOPPLER TRANSDUCER
K905369
Ge Medical Systems Information Technologies
Cardiovascular · 74d
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 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 Aug 10, 1987
SSD-725 ULTRASOUND SECTOR SCANNER
K870607
Ge Medical Systems Information Technologies
Cardiovascular · 180d
Cleared Jul 21, 1987
SSD-633 PHASED ARRAY SECTOR/LINEAR ULTRASOUND SYS.
K870916
Ge Medical Systems Information Technologies
Cardiovascular · 137d
Cleared May 11, 1987
3MHZ ANNULAR ARRAY
K864980
Philips Ultrasound, Inc.
Cardiovascular · 140d
Cleared Jul 24, 1986
MERIDIAN IMAGING SYSTEM
K861737
Johnson & Johnson Professionals, Inc.
Cardiovascular · 79d
Cleared May 08, 1986
ULTRASOUND TRANSDUCER #21230A 7.5MHZ SHORT FOCUS
K860652
Hewlett-Packard Co.
Cardiovascular · 76d
Cleared Apr 14, 1986
ULTRASONIC COUPLANT GEL
K854996
Johnson & Johnson Professionals, Inc.
Cardiovascular · 123d
Cleared Feb 21, 1986
MERIDIAN ULTRASOUND IMAGING SYSTEM
K853240
Johnson & Johnson Professionals, Inc.
Cardiovascular · 204d
Cleared Apr 10, 1985
Q-DOP
K843058
Quinton, Inc.
Cardiovascular · 250d
Cleared Apr 10, 1985
CARDIAC SECTOR PROBE 3.5. MHZ
K850145
Siemens Medical Solutions USA, Inc.
Cardiovascular · 86d
Cleared Apr 10, 1985
CARDIAC SECTOR PROBE 5.0 MHZ
K850216
Siemens Medical Solutions USA, Inc.
Cardiovascular · 78d
Cleared Mar 12, 1985
SCANHEADS-ACCESS 10PV, BIOSTATIC
K843620
Advanced Technology Laboratories, Inc.
Cardiovascular · 179d
Cleared Mar 12, 1985
SCANHEADS ACCESS 10 10PV B10
K843953
Advanced Technology Laboratories, Inc.
Cardiovascular · 154d
Cleared Mar 05, 1985
ACCESS C
K843911
Advanced Technology Laboratories, Inc.
Cardiovascular · 153d
Cleared Dec 20, 1984
ACCESS & 72X ULTRASOUND SCANHEAD UM4
K843131
Advanced Technology Laboratories, Inc.
Cardiovascular · 133d

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 →