FDA Product Code
FDA Product Code JAF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1540
510(k) Clearances — 38 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K242487 | Laminar P1 (LDH-HW-001) | Laminar Digital Health, Inc. | 2024-12-13 | Traditional | PDF ↗ |
| K141657 | THD REVOLUTION | Thd Spa | 2015-02-24 | Traditional | PDF ↗ |
| K110628 | SIMPLEABI | Newman Medical | 2011-05-12 | Traditional | PDF ↗ |
| K093393 | LIFEDOP MODEL 300ABI | Summit Doppler Systems, Inc. | 2009-12-24 | Traditional | PDF ↗ |
| K090009 | THD SLIDE ONE | Thd Spa | 2009-01-28 | Special | PDF ↗ |
| K081429 | THD SLIDE | Thd Spa | 2008-07-30 | Traditional | PDF ↗ |
| K070815 | THD | G.F. S.R.L. | 2007-06-20 | Traditional | PDF ↗ |
| K063600 | VISTA AVS | Summit Doppler Systems, Inc. | 2006-12-19 | Traditional | PDF ↗ |
| K060064 | STETHOFLUX | Odvi | 2006-04-10 | Traditional | PDF ↗ |
| K052067 | DOPPLER GUIDED PROCTOSCOPE, MODEL 500H | Multigon Industries, Inc. | 2005-08-29 | Traditional | PDF ↗ |
| K010521 | NICOLET VERSALAB | Nicolet Biomedical | 2001-03-09 | Special | PDF ↗ |
| K982635 | CAREDOP II | Nicolet Biomedical | 1998-08-07 | Special | PDF ↗ |
| K973336 | IMEX STETHODOP | Imex Medical Systems, Inc. | 1998-02-05 | Traditional | PDF ↗ |
| K973857 | FLOSTAT VASCULAR REPORT GENERATOR (VRG) | Biomedix, Inc. | 1997-12-29 | Traditional | PDF ↗ |
| K973644 | FLOSTAT VASCULAR LAB | Biomedix, Inc. | 1997-12-23 | Traditional | PDF ↗ |
| K943338 | BIOSENSOR BIDOP VASCULAR TEST SYSTEM | Biosensor Corp. | 1996-04-12 | Traditional | PDF ↗ |
| K943200 | FLOSCOPE SUPER VASCULAR LAB | Advance Medical Device, Inc. | 1995-11-21 | Traditional | PDF ↗ |
| K944196 | IMWXDOP IR | Imex Medical Systems, Inc. | 1995-05-12 | Traditional | PDF ↗ |
| K935427 | R AND D BATTERIES | R & D Batteries, Inc. | 1994-10-21 | Traditional | PDF ↗ |
| K942441 | IMEXDOP CT+ | Imex Medical Systems, Inc. | 1994-08-23 | Traditional | PDF ↗ |
| K912925 | ULTRA PVD | Advanced Medical Products, Inc. | 1992-06-18 | Traditional | PDF ↗ |
| K912033 | ULTRASOUND STETHOSCOPE(R) INTRADOP(R) | Medadonics, Inc. | 1991-10-15 | Traditional | PDF ↗ |
| K904392 | MULTILAB 2000 | Unetixs, Inc. | 1991-04-29 | Traditional | PDF ↗ |
| K900882 | MULTI DOPPLEX, MD-1 | Huntleigh Technology, Inc. | 1990-08-22 | Traditional | PDF ↗ |
| K882018 | MEDACORD PVL, PERSONAL VASCULAR LABORATORY | Medasonics, Inc. | 1988-09-21 | Traditional | PDF ↗ |
| K854591 | SUPRASTERNAL NOTCH DOP/TRANS. 3MHZ | Philips Medical Systems, Inc. | 1986-04-23 | Traditional | PDF ↗ |
| K854590 | HANDHELD DOPLER/PEN TRANSDUCER 3MHZ | Philips Medical Systems, Inc. | 1986-04-23 | Traditional | PDF ↗ |
| K851149 | KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1 | Keymed, Inc. | 1985-11-26 | Traditional | PDF ↗ |
| K852572 | 3.5 MHZ CW DOPPLER PROBE MODEL NO. 8421802 | Siemens Medical Solutions USA, Inc. | 1985-09-19 | Traditional | PDF ↗ |
| K844128 | EUB-40 | Hitachi Medical Corp. of America | 1985-02-25 | Traditional | PDF ↗ |
| K843933 | VINGMED DS100 DOPPLER FLOWMETER | Vingmed, Inc. | 1985-02-13 | Traditional | PDF ↗ |
| K842408 | IREX 730 MECHANICAL SECTOR SCANNER | Irex Corp. | 1984-11-29 | Traditional | PDF ↗ |
| K822602 | HEMACOUNT WRIGHT GIEMSA STAIN PACK | Accra Laboratories, Inc. | 1982-09-17 | Traditional | PDF ↗ |
| K800768 | VASCULAB BI-DIRECTIONAL DOPPLER, #D10 | Medasonics, Inc. | 1980-07-08 | Traditional | PDF ↗ |
| K800096 | AMBIVASON DR-200 | Kt Medical, Inc. | 1980-02-11 | Traditional | PDF ↗ |
| K800097 | MINIVASON 9 | Kt Medical, Inc. | 1980-02-11 | Traditional | PDF ↗ |
| K780201 | SPEAKER-AMPLIFIER & RECORDER INTERFACE | L&M Ultrascope Life Monitoring Sys. | 1978-03-02 | Traditional | PDF ↗ |
| K780200 | ULTRASCOPE | L&M Ultrascope Life Monitoring Sys. | 1978-03-02 | Traditional | PDF ↗ |
Product code JAF · Class II · Radiology. Data: openFDA.