Product code JAF
- Device name
- Monitor, Ultrasonic, Nonfetal
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.1540
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242487 | Laminar P1 (LDH-HW-001) | Laminar Digital Health, Inc. | 2024-12-13 |
| K141657 | THD REVOLUTION | Thd Spa | 2015-02-24 |
| K110628 | SIMPLEABI | Newman Medical | 2011-05-12 |
| K093393 | LIFEDOP MODEL 300ABI | Summit Doppler Systems, Inc. | 2009-12-24 |
| K090009 | THD SLIDE ONE | Thd Spa | 2009-01-28 |
| K081429 | THD SLIDE | Thd Spa | 2008-07-30 |
| K070815 | THD | G.F. S.R.L. | 2007-06-20 |
| K063600 | VISTA AVS | Summit Doppler Systems, Inc. | 2006-12-19 |
| K060064 | STETHOFLUX | Odvi | 2006-04-10 |
| K052067 | DOPPLER GUIDED PROCTOSCOPE, MODEL 500H | Multigon Industries, Inc. | 2005-08-29 |
| K010521 | NICOLET VERSALAB | Nicolet Biomedical | 2001-03-09 |
| K982635 | CAREDOP II | Nicolet Biomedical | 1998-08-07 |
| K973336 | IMEX STETHODOP | Imex Medical Systems, Inc. | 1998-02-05 |
| K973857 | FLOSTAT VASCULAR REPORT GENERATOR (VRG) | Biomedix, Inc. | 1997-12-29 |
| K973644 | FLOSTAT VASCULAR LAB | Biomedix, Inc. | 1997-12-23 |
| K943338 | BIOSENSOR BIDOP VASCULAR TEST SYSTEM | Biosensor Corp. | 1996-04-12 |
| K943200 | FLOSCOPE SUPER VASCULAR LAB | Advance Medical Device, Inc. | 1995-11-21 |
| K944196 | IMWXDOP IR | Imex Medical Systems, Inc. | 1995-05-12 |
| K935427 | R AND D BATTERIES | R & D Batteries, Inc. | 1994-10-21 |
| K942441 | IMEXDOP CT+ | Imex Medical Systems, Inc. | 1994-08-23 |
| K912925 | ULTRA PVD | Advanced Medical Products, Inc. | 1992-06-18 |
| K912033 | ULTRASOUND STETHOSCOPE(R) INTRADOP(R) | Medadonics, Inc. | 1991-10-15 |
| K904392 | MULTILAB 2000 | Unetixs, Inc. | 1991-04-29 |
| K900882 | MULTI DOPPLEX, MD-1 | Huntleigh Technology, Inc. | 1990-08-22 |
| K882018 | MEDACORD PVL, PERSONAL VASCULAR LABORATORY | Medasonics, Inc. | 1988-09-21 |
| K854590 | HANDHELD DOPLER/PEN TRANSDUCER 3MHZ | Philips Medical Systems, Inc. | 1986-04-23 |
| K854591 | SUPRASTERNAL NOTCH DOP/TRANS. 3MHZ | Philips Medical Systems, Inc. | 1986-04-23 |
| K851149 | KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1 | Keymed, Inc. | 1985-11-26 |
| K852572 | 3.5 MHZ CW DOPPLER PROBE MODEL NO. 8421802 | Siemens Medical Solutions USA, Inc. | 1985-09-19 |
| K844128 | EUB-40 | Hitachi Medical Corp. of America | 1985-02-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850067960010 | Imex ELITE 3MHZ OB PROBE | IMEX, LLC | 2026-05-18 |
| 00860011754596 | Elite 5 MHz Vascular Probe | IMEX, LLC | 2026-05-18 |
| 00860011754589 | Imex ELITE 8MHZ VASCULAR PROBE | IMEX, LLC | 2026-05-18 |
| 00860011754572 | Imex ELITE 2MHZ OB PROBE | IMEX, LLC | 2026-05-18 |
| 00860011754565 | Imex ELITE 2MHZ WATERPROOF PROBE V2 | IMEX, LLC | 2026-05-18 |
| 00860011754503 | Imex Elite 200 Doppler | IMEX, LLC | 2026-05-13 |
| 00860011754558 | Imex Elite 100R Doppler | IMEX, LLC | 2026-05-13 |
| 00860011754541 | Imex Elite 200R Doppler | IMEX, LLC | 2026-05-13 |
| 00860011754534 | Imex CT+ Doppler | IMEX, LLC | 2026-05-13 |
| 00860011754527 | Imex Elite 100 Doppler | IMEX, LLC | 2026-05-13 |
| 08033737710869 | THD SLIDE ONE | THD SPA | 2025-10-30 |
| 18033737710354 | THD SLIDE ONE | THD SPA | 2025-10-30 |
| 08051887047918 | THD SLIDE ONE | THD SPA | 2025-04-03 |
| 08033737710777 | THD SLIDE ONE | THD SPA | 2022-09-01 |
| 00852785008944 | DigiDop | NEWMAN MEDICAL LLC | 2021-06-25 |
| 00852785008982 | DigiDop | NEWMAN MEDICAL LLC | 2021-06-25 |
| 00852785008975 | DigiDop | NEWMAN MEDICAL LLC | 2021-06-25 |
| 00852785008968 | DigiDop | NEWMAN MEDICAL LLC | 2021-06-25 |
| 00852785008951 | DigiDop | NEWMAN MEDICAL LLC | 2021-06-25 |
| 00852785008937 | DigiDop | NEWMAN MEDICAL LLC | 2021-06-25 |
| 00852785008920 | DigiDop | NEWMAN MEDICAL LLC | 2021-06-25 |
| 00852785008913 | DigiDop | NEWMAN MEDICAL LLC | 2021-06-25 |
| 00852785008906 | DigiDop | NEWMAN MEDICAL LLC | 2021-06-25 |
| 00852785008890 | DigiDop | NEWMAN MEDICAL LLC | 2021-06-25 |
| 00852785008883 | DigiDop | NEWMAN MEDICAL LLC | 2021-06-25 |
| 00852785008876 | DigiDop | NEWMAN MEDICAL LLC | 2021-06-25 |
| 00852785008494 | DigiDop | NEWMAN MEDICAL LLC | 2021-06-25 |
| 00852785008869 | DigiDop | NEWMAN MEDICAL LLC | 2021-06-24 |
| 08033737710739 | THD Revolution | THD SPA | 2016-09-30 |
| 00888937002454 | Summit Doppler | Coopersurgical, Inc. | 2016-07-21 |