Advanced Technology Laboratories, Inc.
Bothell, WA, US
Advanced Technology Laboratories, Inc. appears in FDA device records in Bothell, WA. FDA records list 61 510(k) clearances between and , 3 PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 61
- PMA records
- 3
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 61FDA records hold 61 510(k) clearances for Advanced Technology Laboratories, Inc. between 1980 and 2002. The busiest year on record is 1984, with 10. The most recent is 2002, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 5 |
| 1981 | 6 |
| 1982 | 2 |
| 1983 | 1 |
| 1984 | 10 |
| 1985 | 4 |
| 1986 | 3 |
| 1987 | 7 |
| 1988 | 3 |
| 1989 | 5 |
| 1990 | 5 |
| 1991 | 2 |
| 1994 | 2 |
| 1997 | 1 |
| 1999 | 2 |
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K021966 | Q LAB SOFTWARE | LLZ | Substantially Equivalent | |
| K011224 | HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, AND PANORAMIC MEASUREMENT CAPABILITY | IYN | Substantially Equivalent | |
| K002144 | MEDLINK DIAGNOSTIC OFFLINE WORKSTATION | LLZ | Substantially Equivalent | |
| K992470 | ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM | IYO | Substantially Equivalent | |
| K991671 | HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM | IYO | Substantially Equivalent | |
| K961459 | LEVEL 10 HDI | IYO | Substantially Equivalent | |
| K935009 | PEGASUS | IYN | Substantially Equivalent | |
| K940423 | NOVA MICROSONICS ACCESS IMAGE MANAGEMENT NETWORK/ACCESS ACQUISITION MODULE | LMD | Substantially Equivalent | |
| K905248 | NOVA MICROSONICS CAPRICORN DIGITAL IMAGE SYSTEMS | DQK | Substantially Equivalent | |
| K903603 | ULTRAMARK 9 ULTRASOUND SYSTEM (UM 9) | IYO | Substantially Equivalent | |
| K901329 | CEPHALIC DOPPLER W/ULTRAMARK 9 ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K902214 | BIOPSY NEEDLE TRANSPONDER SYSTEM | IYO | Substantially Equivalent | |
| K903348 | ULTRASONIC PULSED DOPPLER IMAGING SYSTEM | HGL | Substantially Equivalent | |
| K897004 | NOVA MICROSONICS DATAVUE ECHO ANALYSIS SYSTEM | DXG | Substantially Equivalent | |
| K896543 | ULTRAMARK 7 ULTRASOUND SYSTEM | DXK | Substantially Equivalent | |
| K895647 | 5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER | HGL | Substantially Equivalent | |
| K895123 | 5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER | HGL | Substantially Equivalent | |
| K894054 | 5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER | IYN | Substantially Equivalent | |
| K891309 | 5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER | IYO | Substantially Equivalent | |
| K881329 | FETAL DOPPLER FOR ULTRAMARK 4 AND 8 | HEM | Substantially Equivalent | |
| K881140 | ULTRAMARK 4+ ULTRASOUND W/3.5 MHZ 40R CONVEX ARRAY | IYO | Substantially Equivalent | |
| K883546 | TEEC (TRANSESOPHAGEAL ECHOCARDIOGRAPHY) TRANSDUCER | IYO | Substantially Equivalent | |
| K872441 | HIGH FREQ LINEAR ARRAY(HFLA)SCANHEAD W/DPLR SIDEAR | DPT | Substantially Equivalent | |
| K873096 | COLOR FLOW IMAGING | IYO | Substantially Equivalent | |
| K872068 | HIGH FREQUENCY LINEAR ARRAY (HFLA) SCANHEAD | DPW | Substantially Equivalent | |
| K871856 | ANNULAR ARRAY SCANHEAD | HGL | Substantially Equivalent for Some Indications | |
| K871432 | 3.0 MHZ PHASED ARRAY SCANHEAD W/2.0 MHZ SIDEARM CW | ITX | Substantially Equivalent | |
| K871383 | FETALERT ADR FETAL MONITOR | HGM | Substantially Equivalent | |
| K870038 | TRT TRANS-RECTAL TRANSDUCER | ITX | Substantially Equivalent | |
| K864657 | ATL'S ULTRAMARK 6 ULTRASOUND SYSTEM | DXK | Substantially Equivalent | |
| K862681 | ULTRAMARK 1 ULTRASOUND SYSTEM | IYO | Substantially Equivalent | |
| K861109 | CW DOPPLER STATIC TRANSDUCERS | ITX | Substantially Equivalent for Some Indications | |
| K852947 | ADR 3160 W/PROBES PLB-308M, PLB-508M, & PLB-310M | ITX | Substantially Equivalent | |
| K853407 | INTRA VAGINAL TRANSDUCER | HEM | Substantially Equivalent | |
| K843953 | SCANHEADS ACCESS 10 10PV B10 | JOP | Substantially Equivalent | |
| K843620 | SCANHEADS-ACCESS 10PV, BIOSTATIC | JOP | Substantially Equivalent | |
| K843911 | ACCESS C | JOP | Substantially Equivalent | |
| K843165 | ULTRASOUND 72X & ANNULAR ARRAY SCAN- | JOP | Substantially Equivalent | |
| K843131 | ACCESS & 72X ULTRASOUND SCANHEAD UM4 | JOP | Substantially Equivalent | |
| K843130 | SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 4 | JOP | Substantially Equivalent | |
| K843129 | SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 8 | JOP | Substantially Equivalent | |
| K842376 | ULTRAMARK 4 ULTRASOUND SYS | IYO | Substantially Equivalent | |
| K842093 | MK 700 ULTRASOUND SYSTEM | IYO | Substantially Equivalent | |
| K840953 | ACCESS SCANHEADSS | IYN | Substantially Equivalent | |
| K833522 | NEURO SECTOR FIXATION DEVICE | GXW | Substantially Equivalent | |
| K840364 | REGISTREX 1000 PLUS DIGITAL RADIOGRAPHY | JAA | Substantially Equivalent | |
| K833225 | CALIBRE-TENTATIVE TRADENAME | IYO | Substantially Equivalent | |
| K833230 | REGISTREX 1000 DIGITAL RADIOGRAPHY SYS | JAA | Substantially Equivalent | |
| K820365 | MARK 100 & 300 ULTRASOUND SYSTEM | IYO | Substantially Equivalent | |
| K820364 | MARK 500 ULTRASOUOND SYSTEM | IYO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- DQKComputer, Diagnostic, Programmable
- DXKEchocardiograph
- GXWEchoencephalograph
- DPSElectrocardiograph
- DPWFlowmeter, Blood, Cardiovascular
- HEMImager, Ultrasonic Obstetric-Gynecologic
- DPTProbe, Blood-Flow, Extravascular
- LMDSystem, Digital Image Communications, Radiological
- LLZSystem, Image Processing, Radiological
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- HGMSystem, Monitoring, Perinatal
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- JOPTransducer, Ultrasonic
- ITXTransducer, Ultrasonic, Diagnostic
- HGLTransducer, Ultrasonic, Obstetric
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain