Product Code: JOP FDA class 2 21 CFR 870.2880

Transducer, Ultrasonic

Cardiovascular

The Transducer, Ultrasonic is a cardiovascular diagnostic device that converts electrical energy into ultrasonic waves and detects returning echoes to generate images or measurements of cardiac and vascular structures, used in echocardiography and Doppler flow studies for the noninvasive assessment of heart and vessel function. This device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification before marketing. It carries product code JOP and is regulated under 21 CFR 870.2880, within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: JOP
Device Class: FDA class 2
Regulation Number: 870.2880
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 72 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K242662	Falcon/Xpress (Falcon/Xpress)	Dec 18, 2024	Substantially Equivalent	Viasonix , Ltd.
K233976	VasoGuard (V10, V8, V6, V4, V2)	Jul 19, 2024	Substantially Equivalent	Corvascular Diagnostics, LLC
K153762	Smartdop XT6	May 25, 2016	Substantially Equivalent	Koven Technology, Inc.
K131623	SMARTDOP XT	Jan 17, 2014	Substantially Equivalent	Koven Technology, Inc.
K131860	VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING	Sep 27, 2013	Substantially Equivalent	Us Vascular, LLC
K111416	FALCON	Jul 15, 2011	Substantially Equivalent	Viasonix , Ltd.
K071730	STUDIODOP VICORDER	Dec 20, 2007	Substantially Equivalent	Skidmore Medical, Limited
K010482	ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1	Mar 20, 2001	Substantially Equivalent	Echocath, Inc.
K002766	NICOLET VASOGUARD	Nov 30, 2000	Substantially Equivalent	Nicolet Biomedical
K990642	ECHOFLOW DOPPLER BLOOD VELOCITY METER	Sep 16, 1999	Substantially Equivalent	Echocath, Inc.
K925078	SPECTRADOP	Jul 17, 1995	Substantially Equivalent	Bennett and Assoc., Inc.
K934638	REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8	May 13, 1994	Substantially Equivalent	Koven Technology, Inc.
K912409	MODEL HD-207 BIDIRECTIONAL VELOCITY METER	Dec 23, 1991	Substantially Equivalent	Koven and Assoc., Inc.
K911320	EXTRAVASCULAR DOPPLER (EVD) ULTRA BLOOD FLOW PROBE	Dec 18, 1991	Substantially Equivalent	Applied Biometrics, Inc.
K910281	INTRAVASCULAR IMAGING SYSTEM/MODIFIED	May 13, 1991	Substantially Equivalent	Intertherapy, Inc.
K905157	FLOSCOPE VASCULAR LAB.	Mar 15, 1991	Substantially Equivalent	Advance Medical Device, Inc.
K905369	UST-2266U-5 CW DOPPLER TRANSDUCER	Feb 11, 1991	Substantially Equivalent	Ge Medical Systems Information Technologies
K896264	MILLAR MIKRO-TIP DOPPLER CATHETER	Jan 24, 1990	Substantially Equivalent	Millar Instruments, Inc.
K890638	VOLUME COMPUTATION SOFTWARE PACKAGE	Aug 07, 1989	Substantially Equivalent	Elscint, Inc.
K890636	CARDIAC COMPUTATION SOFTWARE PACKAGE	Aug 07, 1989	Substantially Equivalent	Elscint, Inc.
K892944	INTERSPEC TRANSESOPHAGEAL PROBE MODEL 4515	Jul 19, 1989	Substantially Equivalent	Interspec, Inc.
K881979	RESUBMITTAL OF MI 1000C MICROIMAGER	Jun 12, 1989	Substantially Equivalent	Ausonics Pty , Ltd.
K883889	TRANSESOPHAGEAL ECHO TRANSDUCER	Nov 29, 1988	Substantially Equivalent	General Electric Co.
K873674	SDU-700 PHASED ARRAY SECTOR AND LINEAR SCANNER	Oct 07, 1988	Substantially Equivalent	Shimadzu Corp.
K881723	GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER	Aug 12, 1988	Substantially Equivalent	Biosound, Inc.
K871442	BIOSOUND MMI ULTRASOUND	May 20, 1988	Substantially Equivalent	Biosound, Inc.
K873989	DOPPLEX ULTRASONIC DOPPLER SYSTEM	Mar 02, 1988	Substantially Equivalent	Ultramed, Inc.
K870857	ABCOM 1 CARDIAC OUTPUT MONITOR	Nov 16, 1987	Substantially Equivalent	Applied Biometrics, Inc.
K870726	RT5000 ECHOCARDIOGRAPHY #H4100C/CE	Oct 20, 1987	Substantially Equivalent	General Electric Co.
K871727	MODIFIED RADIUS - MODEL NUMBER MM 5000	Sep 30, 1987	Substantially Equivalent	Ultrasonix, Inc.
K871506	ACUSON L538 TRANSDUCER	Sep 28, 1987	Substantially Equivalent	Acuson Computed Sonography
K871416	AUXILIARY CONTINUOUS WAVE DOPPLER TRANSDUCER	Sep 28, 1987	Substantially Equivalent	Acuson Computed Sonography
K870850	MOD 482	Sep 08, 1987	Substantially Equivalent	Hoffrel Instruments, Inc.
K872074	5 MHZ TRANSDUCER	Aug 25, 1987	Substantially Equivalent	Sonicaid, Inc.
K871212	MASCOT CW DOPPLER SYSTEM	Aug 14, 1987	Substantially Equivalent	Imex Medical Systems, Inc.
K870607	SSD-725 ULTRASOUND SECTOR SCANNER	Aug 10, 1987	Substantially Equivalent	Ge Medical Systems Information Technologies
K870150	CONTINUOUS CARDIAC OUTPUT MONITORING SYSTEM	Aug 07, 1987	Substantially Equivalent	Cardio Metrics, Inc.
K870916	SSD-633 PHASED ARRAY SECTOR/LINEAR ULTRASOUND SYS.	Jul 21, 1987	Substantially Equivalent	Ge Medical Systems Information Technologies
K864980	3MHZ ANNULAR ARRAY	May 11, 1987	Substantially Equivalent	Philips Ultrasound, Inc.
K862913	CARDIOSCAN WITH DOPPLER OPTION	Nov 04, 1986	Substantially Equivalent	Interspec, Inc.
K861596	ACUSON S519 TRANSDUCER	Jul 30, 1986	Substantially Equivalent for Some Indications	Acuson Computed Sonography
K861579	ACUSON L558 TRANSDUCER	Jul 30, 1986	Substantially Equivalent for Some Indications	Acuson Computed Sonography
K862159	ACUSON S319 TRANSDUCER	Jul 24, 1986	Substantially Equivalent	Acuson Computed Sonography
K861737	MERIDIAN IMAGING SYSTEM	Jul 24, 1986	Substantially Equivalent for Some Indications	Johnson & Johnson Professionals, Inc.
K861866	ACUSON L382 AND L312 TRANSDUCERS	Jul 18, 1986	Substantially Equivalent	Acuson Computed Sonography
K861378	ULTRAMED TF 122 ULTRASON VASCU IMAG & DOPPLER SYST	Jul 07, 1986	Substantially Equivalent	Ultramed, Inc.
K860579	CARDIOSCAN DOPPLER OPTION	Jun 30, 1986	Substantially Equivalent	Interspec, Inc.
K860652	ULTRASOUND TRANSDUCER #21230A 7.5MHZ SHORT FOCUS	May 08, 1986	Substantially Equivalent	Hewlett-Packard Co.
K854996	ULTRASONIC COUPLANT GEL	Apr 14, 1986	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K853240	MERIDIAN ULTRASOUND IMAGING SYSTEM	Feb 21, 1986	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K853138	MILLAR MIKRO-TIP DOPPLER CATHETER	Oct 29, 1985	Substantially Equivalent	Millar Instruments, Inc.
K850165	MOTOR DRIVE, MECHANICAL SECTOR SCANNING-MOD417	Oct 23, 1985	Substantially Equivalent	Hoffrel Instruments, Inc.
K851616	3.5. MHZ PROBE FOR AUSONICS 150 & 357 REAL TIME CA	Jul 29, 1985	Substantially Equivalent	Ausonics Pty , Ltd.
K851269	DOPLETTE 10	Jul 29, 1985	Substantially Equivalent	Imex Medical Systems, Inc.
K850216	CARDIAC SECTOR PROBE 5.0 MHZ	Apr 10, 1985	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K850145	CARDIAC SECTOR PROBE 3.5. MHZ	Apr 10, 1985	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K843058	Q-DOP	Apr 10, 1985	Substantially Equivalent	Quinton, Inc.
K842539	DIAGNOSTIC ULTRASOUND 105 & 110	Apr 10, 1985	Substantially Equivalent	Diagnostic Ultrasound Corp.
K843953	SCANHEADS ACCESS 10 10PV B10	Mar 12, 1985	Substantially Equivalent	Advanced Technology Laboratories, Inc.
K843620	SCANHEADS-ACCESS 10PV, BIOSTATIC	Mar 12, 1985	Substantially Equivalent	Advanced Technology Laboratories, Inc.
K843911	ACCESS C	Mar 05, 1985	Substantially Equivalent	Advanced Technology Laboratories, Inc.
K843165	ULTRASOUND 72X & ANNULAR ARRAY SCAN-	Dec 20, 1984	Substantially Equivalent	Advanced Technology Laboratories, Inc.
K843131	ACCESS & 72X ULTRASOUND SCANHEAD UM4	Dec 20, 1984	Substantially Equivalent	Advanced Technology Laboratories, Inc.
K843130	SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 4	Dec 06, 1984	Substantially Equivalent	Advanced Technology Laboratories, Inc.
K843129	SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 8	Dec 06, 1984	Substantially Equivalent	Advanced Technology Laboratories, Inc.
K842460	VF-PD-120	Oct 19, 1984	Substantially Equivalent	Valpey-Fisher Corp.
K843262	TRANSESOPHAGEAL ECHOCARDIOGRAPHY ULTRASO	Aug 23, 1984	Substantially Equivalent	Hewlett-Packard Co.
K840542	MINI-DOPPLER ES-100	Jul 16, 1984	Substantially Equivalent	Hayashi Denki Co., Ltd.
K834525	ANGIOSCAN FLO MAD SPECTRUM ANALYZER	May 23, 1984	Substantially Equivalent	Unigon Industries, Inc.
K832369	VASCULAR RECORDER #301	Mar 12, 1984	Substantially Equivalent	Imex Medical Systems, Inc.
K833902	VASOSCAN	Jan 27, 1984	Substantially Equivalent	Sonicaid, Inc.
K810414	USCI DOPPLER CATHETER SYSTEM	Aug 12, 1981	Substantially Equivalent	C.R. Bard, Inc.