Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Advanced Technology Laboratories, Inc. — Predicate Candidate Screening

61 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

97 daysmedian FDA review time
245 days90th percentile
61clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K021966Q LAB SOFTWAREAdvanced Technology Laboratories, Inc.2002-07-02150
K011224HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (AAdvanced Technology Laboratories, Inc.2001-05-04140
K002144MEDLINK DIAGNOSTIC OFFLINE WORKSTATIONAdvanced Technology Laboratories, Inc.2000-09-28730
K992470ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEMAdvanced Technology Laboratories, Inc.1999-08-23280
K991671HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEMAdvanced Technology Laboratories, Inc.1999-06-18320
K961459LEVEL 10 HDIAdvanced Technology Laboratories, Inc.1997-03-263440
K935009PEGASUSAdvanced Technology Laboratories, Inc.1994-10-113560
K940423NOVA MICROSONICS ACCESS IMAGE MANAGEMENT NETWORK/ACCESS ACQUAdvanced Technology Laboratories, Inc.1994-07-291790
K905248NOVA MICROSONICS CAPRICORN DIGITAL IMAGE SYSTEMSAdvanced Technology Laboratories, Inc.1991-02-28990
K903603ULTRAMARK 9 ULTRASOUND SYSTEM (UM 9)Advanced Technology Laboratories, Inc.1991-02-262020
K901329CEPHALIC DOPPLER W/ULTRAMARK 9 ULTRASOUND SYSTEMAdvanced Technology Laboratories, Inc.1990-11-232470
K902214BIOPSY NEEDLE TRANSPONDER SYSTEMAdvanced Technology Laboratories, Inc.1990-11-081760
K903348ULTRASONIC PULSED DOPPLER IMAGING SYSTEMAdvanced Technology Laboratories, Inc.1990-10-22880
K897004NOVA MICROSONICS DATAVUE ECHO ANALYSIS SYSTEMAdvanced Technology Laboratories, Inc.1990-03-13850
K896543ULTRAMARK 7 ULTRASOUND SYSTEMAdvanced Technology Laboratories, Inc.1990-02-15900
K8956475.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCERAdvanced Technology Laboratories, Inc.1989-12-18890
K8951235.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCERAdvanced Technology Laboratories, Inc.1989-11-13900
K8940545.0 MHZ ARRAY INTRAVAGINAL TRANSDUCERAdvanced Technology Laboratories, Inc.1989-09-12970
K8913095.0 MHZ ARRAY INTRAVAGINAL TRANSDUCERAdvanced Technology Laboratories, Inc.1989-05-16670
K881329FETAL DOPPLER FOR ULTRAMARK 4 AND 8Advanced Technology Laboratories, Inc.1989-04-143800
K881140ULTRAMARK 4+ ULTRASOUND W/3.5 MHZ 40R CONVEX ARRAYAdvanced Technology Laboratories, Inc.1988-11-292570
K883546TEEC (TRANSESOPHAGEAL ECHOCARDIOGRAPHY) TRANSDUCERAdvanced Technology Laboratories, Inc.1988-10-07490
K872441HIGH FREQ LINEAR ARRAY(HFLA)SCANHEAD W/DPLR SIDEARAdvanced Technology Laboratories, Inc.1988-02-192450
K873096COLOR FLOW IMAGINGAdvanced Technology Laboratories, Inc.1987-11-231080
K872068HIGH FREQUENCY LINEAR ARRAY (HFLA) SCANHEADAdvanced Technology Laboratories, Inc.1987-09-301240
K871856ANNULAR ARRAY SCANHEADAdvanced Technology Laboratories, Inc.1987-08-281080
K8714323.0 MHZ PHASED ARRAY SCANHEAD W/2.0 MHZ SIDEARM CWAdvanced Technology Laboratories, Inc.1987-08-071160
K871383FETALERT ADR FETAL MONITORAdvanced Technology Laboratories, Inc.1987-06-01550
K870038TRT TRANS-RECTAL TRANSDUCERAdvanced Technology Laboratories, Inc.1987-03-30840
K864657ATL'S ULTRAMARK 6 ULTRASOUND SYSTEMAdvanced Technology Laboratories, Inc.1987-02-02660
K862681ULTRAMARK 1 ULTRASOUND SYSTEMAdvanced Technology Laboratories, Inc.1986-07-1610
K861109CW DOPPLER STATIC TRANSDUCERSAdvanced Technology Laboratories, Inc.1986-07-081050
K852947ADR 3160 W/PROBES PLB-308M, PLB-508M, & PLB-310MAdvanced Technology Laboratories, Inc.1986-01-061790
K853407INTRA VAGINAL TRANSDUCERAdvanced Technology Laboratories, Inc.1985-09-27460
K843953SCANHEADS ACCESS 10 10PV B10Advanced Technology Laboratories, Inc.1985-03-121540
K843620SCANHEADS-ACCESS 10PV, BIOSTATICAdvanced Technology Laboratories, Inc.1985-03-121790
K843911ACCESS CAdvanced Technology Laboratories, Inc.1985-03-051530
K843131ACCESS & 72X ULTRASOUND SCANHEAD UM4Advanced Technology Laboratories, Inc.1984-12-201330
K843165ULTRASOUND 72X & ANNULAR ARRAY SCAN-Advanced Technology Laboratories, Inc.1984-12-201290
K843130SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 4Advanced Technology Laboratories, Inc.1984-12-061190
K843129SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 8Advanced Technology Laboratories, Inc.1984-12-061190
K842376ULTRAMARK 4 ULTRASOUND SYSAdvanced Technology Laboratories, Inc.1984-10-051090
K842093MK 700 ULTRASOUND SYSTEMAdvanced Technology Laboratories, Inc.1984-09-271260
K840953ACCESS SCANHEADSSAdvanced Technology Laboratories, Inc.1984-06-151020
K833522NEURO SECTOR FIXATION DEVICEAdvanced Technology Laboratories, Inc.1984-05-252490
K840364REGISTREX 1000 PLUS DIGITAL RADIOGRAPHYAdvanced Technology Laboratories, Inc.1984-03-19530
K833225CALIBRE-TENTATIVE TRADENAMEAdvanced Technology Laboratories, Inc.1984-02-281810
K833230REGISTREX 1000 DIGITAL RADIOGRAPHY SYSAdvanced Technology Laboratories, Inc.1983-11-21890
K820365MARK 100 & 300 ULTRASOUND SYSTEMAdvanced Technology Laboratories, Inc.1982-03-26450
K820364MARK 500 ULTRASOUOND SYSTEMAdvanced Technology Laboratories, Inc.1982-03-26450

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda