Advanced Technology Laboratories, Inc.
Medical device manufacturer in Bothell, WA.
61510(k) clearances
1PMA approvals
0recalls
Device types
- IYO System, Imaging, Pulsed Echo, Ultrasonic 20
- ITX Transducer, Ultrasonic, Diagnostic 7
- JOP Transducer, Ultrasonic 7
- IYN System, Imaging, Pulsed Doppler, Ultrasonic 6
- HGL Transducer, Ultrasonic, Obstetric 4
- DXK Echocardiograph 3
- LLZ System, Image Processing, Radiological 2
- HEM Imager, Ultrasonic Obstetric-Gynecologic 2
- JAA System, X-Ray, Fluoroscopic… 2
- GXW Echoencephalograph 1
- HGM System, Monitoring, Perinatal 1
- DPW Flowmeter, Blood, Cardiovascular 1
- DPT Probe, Blood-Flow, Extravascular 1
- DXG Computer, Diagnostic, Pre-Programmed… 1
- DQK Computer, Diagnostic, Programmable 1
- LMD System, Digital Image Communications… 1
- DPS Electrocardiograph 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K021966 | Q Lab SoftwareLLZ · Traditional | 07/02/2002SE |
| K011224 | Hdi 5000 Ultrasound System with Assisted Border Detection (Abd), Xres Imaging, and…IYN · Traditional | 05/04/2001SE |
| K002144 | Medlink Diagnostic Offline WorkstationLLZ · Traditional | 09/28/2000SE |
| K992470 | Ultramark 400C/SONOACE 6000 Ultrasound SystemIYO · Traditional | 08/23/1999SE |
| K991671 | Hdi 5000 Diagnostic Ultrasound SystemIYO · Traditional | 06/18/1999SE |
| K961459 | Level 10 HdiIYO · Traditional | 03/26/1997SE |
| K935009 | PegasusIYN · Traditional | 10/11/1994SE |
| K940423 | Nova Microsonics Access Image Management Network/Access Acquisition ModuleLMD · Traditional | 07/29/1994SE |
| K905248 | Nova Microsonics Capricorn Digital Image SystemsDQK · Traditional | 02/28/1991SE |
| K903603 | Ultramark 9 Ultrasound System (Um 9)IYO · Traditional | 02/26/1991SE |
| K901329 | Cephalic Doppler W/Ultramark 9 Ultrasound SystemIYN · Traditional | 11/23/1990SE |
| K902214 | Biopsy Needle Transponder SystemIYO · Traditional | 11/08/1990SE |
| K903348 | Ultrasonic Pulsed Doppler Imaging SystemHGL · Traditional | 10/22/1990SE |
| K897004 | Nova Microsonics Datavue Echo Analysis SystemDXG · Traditional | 03/13/1990SE |
| K896543 | Ultramark 7 Ultrasound SystemDXK · Traditional | 02/15/1990SE |
| K895647 | 5.0 MHZ Convex Array Intravaginal TransducerHGL · Traditional | 12/18/1989SE |
| K895123 | 5.0 MHZ Convex Array Intravaginal TransducerHGL · Traditional | 11/13/1989SE |
| K894054 | 5.0 MHZ Array Intravaginal TransducerIYN · Traditional | 09/12/1989SE |
| K891309 | 5.0 MHZ Array Intravaginal TransducerIYO · Traditional | 05/16/1989SE |
| K881329 | Fetal Doppler for Ultramark 4 and 8HEM · Traditional | 04/14/1989SE |
| K881140 | Ultramark 4+ Ultrasound W/3.5 MHZ 40R Convex ArrayIYO · Traditional | 11/29/1988SE |
| K883546 | Teec (Transesophageal Echocardiography) TransducerIYO · Traditional | 10/07/1988SE |
| K872441 | High Freq Linear Array(Hfla)Scanhead W/Dplr SidearDPT · Traditional | 02/19/1988SE |
| K873096 | Color Flow ImagingIYO · Traditional | 11/23/1987SE |
| K872068 | High Frequency Linear Array (Hfla) ScanheadDPW · Traditional | 09/30/1987SE |
| K871856 | Annular Array ScanheadHGL · Traditional | 08/28/1987SN |
| K871432 | 3.0 MHZ Phased Array Scanhead W/2.0 MHZ Sidearm CWITX · Traditional | 08/07/1987SE |
| K871383 | Fetalert Adr Fetal MonitorHGM · Traditional | 06/01/1987SE |
| K870038 | TRT Trans-Rectal TransducerITX · Traditional | 03/30/1987SE |
| K864657 | Atl's Ultramark 6 Ultrasound SystemDXK · Traditional | 02/02/1987SE |
| K862681 | Ultramark 1 Ultrasound SystemIYO · Traditional | 07/16/1986SE |
| K861109 | CW Doppler Static TransducersITX · Traditional | 07/08/1986SN |
| K852947 | Adr 3160 W/Probes PLB-308M, PLB-508M, & PLB-310MITX · Traditional | 01/06/1986SE |
| K853407 | Intra Vaginal TransducerHEM · Traditional | 09/27/1985SE |
| K843953 | Scanheads Access 10 10PV B10JOP · Traditional | 03/12/1985SE |
| K843620 | Scanheads-Access 10PV, BiostaticJOP · Traditional | 03/12/1985SE |
| K843911 | Access CJOP · Traditional | 03/05/1985SE |
| K843165 | Ultrasound 72X & Annular Array Scan-JOP · Traditional | 12/20/1984SE |
| K843131 | Access & 72X Ultrasound Scanhead UM4JOP · Traditional | 12/20/1984SE |
| K843130 | Scanhead 2.25MHZ Added to Ultramark 4JOP · Traditional | 12/06/1984SE |
| K843129 | Scanhead 2.25MHZ Added to Ultramark 8JOP · Traditional | 12/06/1984SE |
| K842376 | Ultramark 4 Ultrasound SysIYO · Traditional | 10/05/1984SE |
| K842093 | MK 700 Ultrasound SystemIYO · Traditional | 09/27/1984SE |
| K840953 | Access ScanheadssIYN · Traditional | 06/15/1984SE |
| K833522 | Neuro Sector Fixation DeviceGXW · Traditional | 05/25/1984SE |
| K840364 | Registrex 1000 Plus Digital RadiographyJAA · Traditional | 03/19/1984SE |
| K833225 | Calibre-Tentative TradenameIYO · Traditional | 02/28/1984SE |
| K833230 | Registrex 1000 Digital Radiography SysJAA · Traditional | 11/21/1983SE |
| K820365 | Mark 100 & 300 Ultrasound SystemIYO · Traditional | 03/26/1982SE |
| K820364 | Mark 500 Ultrasouond SystemIYO · Traditional | 03/26/1982SE |
| K811572 | Atl's Mark 100/300 Ultrasound SystemsIYO · Traditional | 08/10/1981SE |
| K810073 | Mark 500 SystemIYO · Traditional | 03/05/1981SE |
| K802438 | Mark V Duplex Ultrasonic Scan Sys.ITX · Traditional | 01/21/1981SE |
| K803309 | Vitastat ECG-1/ECG-3 ElectrocardiographDPS · Traditional | 01/16/1981SE |
| K802917 | Mark III Ultrasonic Scanning SystemDXK · Traditional | 01/16/1981SE |
| K802437 | Mark III Ultrasonic Scanning SystemIYO · Traditional | 01/15/1981SE |
| K801973 | In-Line Scan Head Mark IV Duplex UltraITX · Traditional | 10/23/1980SE |
| K801972 | True Spectrum Analysis/Mark IV DuplexIYN · Traditional | 10/23/1980SE |
| K801971 | In-Line Scan Head Modification Mark IIIITX · Traditional | 10/23/1980SE |
| K801598 | Mark V Duplex Ultrasonic Scanning SystemIYO · Traditional | 08/20/1980SE |
| K801406 | Mark III Ultrasonic Scanning SystemIYO · Traditional | 07/28/1980SE |
PMA approvals
- P940005 Ultramark 9 High Definition Imaging Uultrasound System · 04/11/1996 · 2 supplements