Product Code: JAF FDA class 2 21 CFR 892.1540

Monitor, Ultrasonic, Nonfetal

Radiology

A nonfetal ultrasonic monitor uses sound waves to detect and display physiological parameters or anatomical features in non-obstetric applications, such as monitoring blood flow or tissue movement in adult patients. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification before marketing. The product code is JAF, regulated under 21 CFR 892.1540, within the Radiology medical specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: JAF
Device Class: FDA class 2
Regulation Number: 892.1540
Medical Specialty: Radiology
Review Panel: RA
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 38 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K242487	Laminar P1 (LDH-HW-001)	Dec 13, 2024	Substantially Equivalent	Laminar Digital Health, Inc.
K141657	THD REVOLUTION	Feb 24, 2015	Substantially Equivalent	Thd Spa
K110628	SIMPLEABI	May 12, 2011	Substantially Equivalent	Newman Medical
K093393	LIFEDOP MODEL 300ABI	Dec 24, 2009	Substantially Equivalent	Summit Doppler Systems, Inc.
K090009	THD SLIDE ONE	Jan 28, 2009	Substantially Equivalent	Thd Spa
K081429	THD SLIDE	Jul 30, 2008	Substantially Equivalent	Thd Spa
K070815	THD	Jun 20, 2007	Substantially Equivalent	G.F. S.R.L.
K063600	VISTA AVS	Dec 19, 2006	Substantially Equivalent	Summit Doppler Systems, Inc.
K060064	STETHOFLUX	Apr 10, 2006	Substantially Equivalent	Odvi
K052067	DOPPLER GUIDED PROCTOSCOPE, MODEL 500H	Aug 29, 2005	Substantially Equivalent	Multigon Industries, Inc.
K010521	NICOLET VERSALAB	Mar 09, 2001	Substantially Equivalent	Nicolet Biomedical
K982635	CAREDOP II	Aug 07, 1998	Substantially Equivalent	Nicolet Biomedical
K973336	IMEX STETHODOP	Feb 05, 1998	Substantially Equivalent	Imex Medical Systems, Inc.
K973857	FLOSTAT VASCULAR REPORT GENERATOR (VRG)	Dec 29, 1997	Substantially Equivalent	Biomedix, Inc.
K973644	FLOSTAT VASCULAR LAB	Dec 23, 1997	Substantially Equivalent	Biomedix, Inc.
K943338	BIOSENSOR BIDOP VASCULAR TEST SYSTEM	Apr 12, 1996	Substantially Equivalent	Biosensor Corp.
K943200	FLOSCOPE SUPER VASCULAR LAB	Nov 21, 1995	Substantially Equivalent	Advance Medical Device, Inc.
K944196	IMWXDOP IR	May 12, 1995	Substantially Equivalent	Imex Medical Systems, Inc.
K935427	R AND D BATTERIES	Oct 21, 1994	Substantially Equivalent	R & D Batteries, Inc.
K942441	IMEXDOP CT+	Aug 23, 1994	Substantially Equivalent	Imex Medical Systems, Inc.
K912925	ULTRA PVD	Jun 18, 1992	Substantially Equivalent	Advanced Medical Products, Inc.
K912033	ULTRASOUND STETHOSCOPE(R) INTRADOP(R)	Oct 15, 1991	Substantially Equivalent	Medadonics, Inc.
K904392	MULTILAB 2000	Apr 29, 1991	Substantially Equivalent	Unetixs, Inc.
K900882	MULTI DOPPLEX, MD-1	Aug 22, 1990	Substantially Equivalent	Huntleigh Technology, Inc.
K882018	MEDACORD PVL, PERSONAL VASCULAR LABORATORY	Sep 21, 1988	Substantially Equivalent	Medasonics, Inc.
K854591	SUPRASTERNAL NOTCH DOP/TRANS. 3MHZ	Apr 23, 1986	Substantially Equivalent	Philips Medical Systems, Inc.
K854590	HANDHELD DOPLER/PEN TRANSDUCER 3MHZ	Apr 23, 1986	Substantially Equivalent	Philips Medical Systems, Inc.
K851149	KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1	Nov 26, 1985	Substantially Equivalent	Keymed, Inc.
K852572	3.5 MHZ CW DOPPLER PROBE MODEL NO. 8421802	Sep 19, 1985	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K844128	EUB-40	Feb 25, 1985	Substantially Equivalent	Hitachi Medical Corp. of America
K843933	VINGMED DS100 DOPPLER FLOWMETER	Feb 13, 1985	Substantially Equivalent	Vingmed, Inc.
K842408	IREX 730 MECHANICAL SECTOR SCANNER	Nov 29, 1984	Substantially Equivalent	Irex Corp.
K822602	HEMACOUNT WRIGHT GIEMSA STAIN PACK	Sep 17, 1982	Substantially Equivalent	Accra Laboratories, Inc.
K800768	VASCULAB BI-DIRECTIONAL DOPPLER, #D10	Jul 08, 1980	Substantially Equivalent	Medasonics, Inc.
K800097	MINIVASON 9	Feb 11, 1980	Substantially Equivalent	Kt Medical, Inc.
K800096	AMBIVASON DR-200	Feb 11, 1980	Substantially Equivalent	Kt Medical, Inc.
K780201	SPEAKER-AMPLIFIER & RECORDER INTERFACE	Mar 02, 1978	Substantially Equivalent	L&M Ultrascope Life Monitoring Sys.
K780200	ULTRASCOPE	Mar 02, 1978	Substantially Equivalent	L&M Ultrascope Life Monitoring Sys.