Atlas FDA

JOP

72 FDA 510(k) clearances · Product code

141 daysmedian time to decision
258 days90th percentile
72clearances measured

FDA profile

Official device name
Transducer, Ultrasonic
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2880
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2000: 2 · 2001: 1 · 2002: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Falcon/Xpress (Falcon/Xpress) (K242662)Viasonix , Ltd.2024-12-18
VasoGuard (V10, V8, V6, V4, V2) (K233976)Corvascular Diagnostics, LLC2024-07-19
Smartdop XT6 (K153762)Koven Technology, Inc.2016-05-25
SMARTDOP XT (K131623)Koven Technology, Inc.2014-01-17
VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING (K131860)Us Vascular, LLC2013-09-27
FALCON (K111416)Viasonix , Ltd.2011-07-15
STUDIODOP VICORDER (K071730)Skidmore Medical, Limited2007-12-20
ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1 (K010482)Echocath, Inc.2001-03-20
NICOLET VASOGUARD (K002766)Nicolet Biomedical2000-11-30
ECHOFLOW DOPPLER BLOOD VELOCITY METER (K990642)Echocath, Inc.1999-09-16
SPECTRADOP (K925078)Bennett and Assoc., Inc.1995-07-17
REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8 (K934638)Koven Technology, Inc.1994-05-13
MODEL HD-207 BIDIRECTIONAL VELOCITY METER (K912409)Koven and Assoc., Inc.1991-12-23
EXTRAVASCULAR DOPPLER (EVD) ULTRA BLOOD FLOW PROBE (K911320)Applied Biometrics, Inc.1991-12-18
INTRAVASCULAR IMAGING SYSTEM/MODIFIED (K910281)Intertherapy, Inc.1991-05-13
FLOSCOPE VASCULAR LAB. (K905157)Advance Medical Device, Inc.1991-03-15
UST-2266U-5 CW DOPPLER TRANSDUCER (K905369)Ge Medical Systems Information Technologies1991-02-11
MILLAR MIKRO-TIP DOPPLER CATHETER (K896264)Millar Instruments, Inc.1990-01-24
CARDIAC COMPUTATION SOFTWARE PACKAGE (K890636)Elscint, Inc.1989-08-07
VOLUME COMPUTATION SOFTWARE PACKAGE (K890638)Elscint, Inc.1989-08-07
INTERSPEC TRANSESOPHAGEAL PROBE MODEL 4515 (K892944)Interspec, Inc.1989-07-19
RESUBMITTAL OF MI 1000C MICROIMAGER (K881979)Ausonics Pty , Ltd.1989-06-12
TRANSESOPHAGEAL ECHO TRANSDUCER (K883889)General Electric Co.1988-11-29
SDU-700 PHASED ARRAY SECTOR AND LINEAR SCANNER (K873674)Shimadzu Corp.1988-10-07
GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER (K881723)Biosound, Inc.1988-08-12
BIOSOUND MMI ULTRASOUND (K871442)Biosound, Inc.1988-05-20
DOPPLEX ULTRASONIC DOPPLER SYSTEM (K873989)Ultramed, Inc.1988-03-02
ABCOM 1 CARDIAC OUTPUT MONITOR (K870857)Applied Biometrics, Inc.1987-11-16
RT5000 ECHOCARDIOGRAPHY #H4100C/CE (K870726)General Electric Co.1987-10-20
MODIFIED RADIUS - MODEL NUMBER MM 5000 (K871727)Ultrasonix, Inc.1987-09-30
AUXILIARY CONTINUOUS WAVE DOPPLER TRANSDUCER (K871416)Acuson Computed Sonography1987-09-28
ACUSON L538 TRANSDUCER (K871506)Acuson Computed Sonography1987-09-28
MOD 482 (K870850)Hoffrel Instruments, Inc.1987-09-08
5 MHZ TRANSDUCER (K872074)Sonicaid, Inc.1987-08-25
MASCOT CW DOPPLER SYSTEM (K871212)Imex Medical Systems, Inc.1987-08-14
SSD-725 ULTRASOUND SECTOR SCANNER (K870607)Ge Medical Systems Information Technologies1987-08-10
CONTINUOUS CARDIAC OUTPUT MONITORING SYSTEM (K870150)Cardio Metrics, Inc.1987-08-07
SSD-633 PHASED ARRAY SECTOR/LINEAR ULTRASOUND SYS. (K870916)Ge Medical Systems Information Technologies1987-07-21
3MHZ ANNULAR ARRAY (K864980)Philips Ultrasound, Inc.1987-05-11
CARDIOSCAN WITH DOPPLER OPTION (K862913)Interspec, Inc.1986-11-04
ACUSON L558 TRANSDUCER (K861579)Acuson Computed Sonography1986-07-30
ACUSON S519 TRANSDUCER (K861596)Acuson Computed Sonography1986-07-30
ACUSON S319 TRANSDUCER (K862159)Acuson Computed Sonography1986-07-24
MERIDIAN IMAGING SYSTEM (K861737)Johnson & Johnson Professionals, Inc.1986-07-24
ACUSON L382 AND L312 TRANSDUCERS (K861866)Acuson Computed Sonography1986-07-18
ULTRAMED TF 122 ULTRASON VASCU IMAG & DOPPLER SYST (K861378)Ultramed, Inc.1986-07-07
CARDIOSCAN DOPPLER OPTION (K860579)Interspec, Inc.1986-06-30
ULTRASOUND TRANSDUCER #21230A 7.5MHZ SHORT FOCUS (K860652)Hewlett-Packard Co.1986-05-08
ULTRASONIC COUPLANT GEL (K854996)Johnson & Johnson Professionals, Inc.1986-04-14
MERIDIAN ULTRASOUND IMAGING SYSTEM (K853240)Johnson & Johnson Professionals, Inc.1986-02-21
MILLAR MIKRO-TIP DOPPLER CATHETER (K853138)Millar Instruments, Inc.1985-10-29
MOTOR DRIVE, MECHANICAL SECTOR SCANNING-MOD417 (K850165)Hoffrel Instruments, Inc.1985-10-23
DOPLETTE 10 (K851269)Imex Medical Systems, Inc.1985-07-29
3.5. MHZ PROBE FOR AUSONICS 150 & 357 REAL TIME CA (K851616)Ausonics Pty , Ltd.1985-07-29
Q-DOP (K843058)Quinton, Inc.1985-04-10
CARDIAC SECTOR PROBE 5.0 MHZ (K850216)Siemens Medical Solutions USA, Inc.1985-04-10
CARDIAC SECTOR PROBE 3.5. MHZ (K850145)Siemens Medical Solutions USA, Inc.1985-04-10
DIAGNOSTIC ULTRASOUND 105 & 110 (K842539)Diagnostic Ultrasound Corp.1985-04-10
SCANHEADS ACCESS 10 10PV B10 (K843953)Advanced Technology Laboratories, Inc.1985-03-12
SCANHEADS-ACCESS 10PV, BIOSTATIC (K843620)Advanced Technology Laboratories, Inc.1985-03-12
ACCESS C (K843911)Advanced Technology Laboratories, Inc.1985-03-05
ACCESS & 72X ULTRASOUND SCANHEAD UM4 (K843131)Advanced Technology Laboratories, Inc.1984-12-20
ULTRASOUND 72X & ANNULAR ARRAY SCAN- (K843165)Advanced Technology Laboratories, Inc.1984-12-20
SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 4 (K843130)Advanced Technology Laboratories, Inc.1984-12-06
SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 8 (K843129)Advanced Technology Laboratories, Inc.1984-12-06
VF-PD-120 (K842460)Valpey-Fisher Corp.1984-10-19
TRANSESOPHAGEAL ECHOCARDIOGRAPHY ULTRASO (K843262)Hewlett-Packard Co.1984-08-23
MINI-DOPPLER ES-100 (K840542)Hayashi Denki Co., Ltd.1984-07-16
ANGIOSCAN FLO MAD SPECTRUM ANALYZER (K834525)Unigon Industries, Inc.1984-05-23
VASCULAR RECORDER #301 (K832369)Imex Medical Systems, Inc.1984-03-12
VASOSCAN (K833902)Sonicaid, Inc.1984-01-27
USCI DOPPLER CATHETER SYSTEM (K810414)C.R. Bard, Inc.1981-08-12

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Every clearance here is in the API, with alerts when new ones post.