JAF · Monitor, Ultrasonic, Nonfetal
Radiology · 21 CFR 892.1540 · Class 2
Overview
| Product Code | JAF |
|---|---|
| Device Name | Monitor, Ultrasonic, Nonfetal |
| Regulation | 21 CFR 892.1540 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
Identification
A nonfetal ultrasonic monitor is a device that projects a continuous high-frequency sound wave into body tissue other than a fetus to determine frequency changes (doppler shift) in the reflected wave and is intended for use in the investigation of nonfetal blood flow and other nonfetal body tissues in motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 38)
Showing 20 most recent of 38 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242487 | Laminar P1 (LDH-HW-001) | Laminar Digital Health, Inc. | Dec 13, 2024 | SESE |
| K141657 | THD REVOLUTION | Thd Spa | Feb 24, 2015 | SESE |
| K110628 | SIMPLEABI | Newman Medical | May 12, 2011 | SESE |
| K093393 | LIFEDOP MODEL 300ABI | Summit Doppler Systems, Inc. | Dec 24, 2009 | SESE |
| K090009 | THD SLIDE ONE | Thd Spa | Jan 28, 2009 | SESE |
| K081429 | THD SLIDE | Thd Spa | Jul 30, 2008 | SESE |
| K070815 | THD | G.F. S.R.L. | Jun 20, 2007 | SESE |
| K063600 | VISTA AVS | Summit Doppler Systems, Inc. | Dec 19, 2006 | SESE |
| K060064 | STETHOFLUX | Odvi | Apr 10, 2006 | SESE |
| K052067 | DOPPLER GUIDED PROCTOSCOPE, MODEL 500H | Multigon Industries, Inc. | Aug 29, 2005 | SESE |
| K010521 | NICOLET VERSALAB | Nicolet Biomedical | Mar 9, 2001 | SESE |
| K982635 | CAREDOP II | Nicolet Biomedical | Aug 7, 1998 | SESE |
| K973336 | IMEX STETHODOP | Imex Medical Systems, Inc. | Feb 5, 1998 | SESE |
| K973857 | FLOSTAT VASCULAR REPORT GENERATOR (VRG) | Biomedix, Inc. | Dec 29, 1997 | SESE |
| K973644 | FLOSTAT VASCULAR LAB | Biomedix, Inc. | Dec 23, 1997 | SESE |
| K943338 | BIOSENSOR BIDOP VASCULAR TEST SYSTEM | Biosensor Corp. | Apr 12, 1996 | SESE |
| K943200 | FLOSCOPE SUPER VASCULAR LAB | Advance Medical Device, Inc. | Nov 21, 1995 | SESE |
| K944196 | IMWXDOP IR | Imex Medical Systems, Inc. | May 12, 1995 | SESE |
| K935427 | R AND D BATTERIES | R & D Batteries, Inc. | Oct 21, 1994 | SESE |
| K942441 | IMEXDOP CT+ | Imex Medical Systems, Inc. | Aug 23, 1994 | SESE |
Top Applicants
- Thd Spa — 3 clearances
- Imex Medical Systems, Inc. — 3 clearances
- Summit Doppler Systems, Inc. — 2 clearances
- Philips Medical Systems, Inc. — 2 clearances
- Nicolet Biomedical — 2 clearances
