Product code JAF— Radiology

FDA has cleared 38 devices under product code JAF between 1978 and 2024, filed by 27 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20241 clearance
• 20151 clearance
• 20111 clearance
• 20092 clearances
• 20081 clearance
• 20071 clearance
• 20062 clearances
• 20051 clearance
• 20011 clearance
• 19982 clearances
• 19972 clearances
• 19961 clearance
• 19952 clearances
• 19942 clearances
• 19921 clearance

• Thd Spa3 clearances
• Imex Medical Systems, Inc.3 clearances
• Summit Doppler Systems, Inc.2 clearances
• Philips Medical Systems, Inc.2 clearances
• Nicolet Biomedical2 clearances
• Medasonics, Inc.2 clearances
• L&M Ultrascope Life Monitoring Sys.2 clearances
• Kt Medical, Inc.2 clearances
• Biomedix, Inc.2 clearances
• Vingmed, Inc.1 clearance

• K242487 — Laminar P1 (LDH-HW-001)Laminar Digital Health, Inc.·2024-12-13
• K141657 — THD REVOLUTIONThd Spa·2015-02-24
• K110628 — SIMPLEABINewman Medical·2011-05-12
• K093393 — LIFEDOP MODEL 300ABISummit Doppler Systems, Inc.·2009-12-24
• K090009 — THD SLIDE ONEThd Spa·2009-01-28
• K081429 — THD SLIDEThd Spa·2008-07-30
• K070815 — THDG.F. S.R.L.·2007-06-20
• K063600 — VISTA AVSSummit Doppler Systems, Inc.·2006-12-19
• K060064 — STETHOFLUXOdvi·2006-04-10
• K052067 — DOPPLER GUIDED PROCTOSCOPE, MODEL 500HMultigon Industries, Inc.·2005-08-29
• K010521 — NICOLET VERSALABNicolet Biomedical·2001-03-09
• K982635 — CAREDOP IINicolet Biomedical·1998-08-07
• K973336 — IMEX STETHODOPImex Medical Systems, Inc.·1998-02-05
• K973857 — FLOSTAT VASCULAR REPORT GENERATOR (VRG)Biomedix, Inc.·1997-12-29
• K973644 — FLOSTAT VASCULAR LABBiomedix, Inc.·1997-12-23
• K943338 — BIOSENSOR BIDOP VASCULAR TEST SYSTEMBiosensor Corp.·1996-04-12
• K943200 — FLOSCOPE SUPER VASCULAR LABAdvance Medical Device, Inc.·1995-11-21
• K944196 — IMWXDOP IRImex Medical Systems, Inc.·1995-05-12
• K935427 — R AND D BATTERIESR & D Batteries, Inc.·1994-10-21
• K942441 — IMEXDOP CT+Imex Medical Systems, Inc.·1994-08-23
• K912925 — ULTRA PVDAdvanced Medical Products, Inc.·1992-06-18
• K912033 — ULTRASOUND STETHOSCOPE(R) INTRADOP(R)Medadonics, Inc.·1991-10-15
• K904392 — MULTILAB 2000Unetixs, Inc.·1991-04-29
• K900882 — MULTI DOPPLEX, MD-1Huntleigh Technology, Inc.·1990-08-22
• K882018 — MEDACORD PVL, PERSONAL VASCULAR LABORATORYMedasonics, Inc.·1988-09-21
• K854590 — HANDHELD DOPLER/PEN TRANSDUCER 3MHZPhilips Medical Systems, Inc.·1986-04-23
• K854591 — SUPRASTERNAL NOTCH DOP/TRANS. 3MHZPhilips Medical Systems, Inc.·1986-04-23
• K851149 — KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1Keymed, Inc.·1985-11-26
• K852572 — 3.5 MHZ CW DOPPLER PROBE MODEL NO. 8421802Siemens Medical Solutions USA, Inc.·1985-09-19
• K844128 — EUB-40Hitachi Medical Corp. of America·1985-02-25
• K843933 — VINGMED DS100 DOPPLER FLOWMETERVingmed, Inc.·1985-02-13
• K842408 — IREX 730 MECHANICAL SECTOR SCANNERIrex Corp.·1984-11-29
• K822602 — HEMACOUNT WRIGHT GIEMSA STAIN PACKAccra Laboratories, Inc.·1982-09-17
• K800768 — VASCULAB BI-DIRECTIONAL DOPPLER, #D10Medasonics, Inc.·1980-07-08
• K800096 — AMBIVASON DR-200Kt Medical, Inc.·1980-02-11
• K800097 — MINIVASON 9Kt Medical, Inc.·1980-02-11
• K780200 — ULTRASCOPEL&M Ultrascope Life Monitoring Sys.·1978-03-02
• K780201 — SPEAKER-AMPLIFIER & RECORDER INTERFACEL&M Ultrascope Life Monitoring Sys.·1978-03-02