510(k) Report

FDA applicant

Advanced Technology Laboratories, Inc.

Bothell, WA62 decisions1980–20020 recalls

FDA records 62 decisions for Advanced Technology Laboratories, Inc. (Bothell, WA) from 1980 to 2002: 61 510(k) clearances and 1 original PMA approval. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and ITX (Transducer, Ultrasonic, Diagnostic). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Advanced Technology Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Advanced Technology Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Advanced Technology Laboratories, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic20decisions
  • ITXTransducer, Ultrasonic, Diagnostic7decisions
  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic7decisions
  • JOPTransducer, Ultrasonic7decisions
  • HGLTransducer, Ultrasonic, Obstetric4decisions
  • DXKEchocardiograph3decisions

Also: JAA (2), HEM (2), LLZ (2), DXG (1), DQK (1), LMD (1).

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 49 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K961459Level 10 HdiAdvanced Technology Laboratories, Inc. · 199716cite it
  • K021966Q Lab SoftwareAdvanced Technology Laboratories, Inc. · 200214cite it
  • K011224Hdi 5000 Ultrasound System with Assisted Border Detection (Abd), Xres Imaging, and Panoramic Measurement…Advanced Technology Laboratories, Inc. · 200110cite it
  • K935009PegasusAdvanced Technology Laboratories, Inc. · 19944cite it
  • K991671Hdi 5000 Diagnostic Ultrasound SystemAdvanced Technology Laboratories, Inc. · 19992cite it
  • K903603Ultramark 9 Ultrasound System (UM 9)Advanced Technology Laboratories, Inc. · 19912cite it

What has FDA decided for it lately?

  • K021966Q Lab SoftwareAdvanced Technology Laboratories, Inc. · 2002
  • K011224Hdi 5000 Ultrasound System with Assisted Border Detection (Abd), Xres Imaging, and Panoramic Measurement…Advanced Technology Laboratories, Inc. · 2001
  • K002144Medlink Diagnostic Offline WorkstationAdvanced Technology Laboratories, Inc. · 2000
  • K992470Ultramark 400C/Sonoace 6000 Ultrasound SystemAdvanced Technology Laboratories, Inc. · 1999
  • K991671Hdi 5000 Diagnostic Ultrasound SystemAdvanced Technology Laboratories, Inc. · 1999
  • K961459Level 10 HdiAdvanced Technology Laboratories, Inc. · 1997
  • P940005Ultramark 9 High Definition Imaging Uultrasound SystemAdvanced Technology Laboratories, Inc. · 1996
  • K935009PegasusAdvanced Technology Laboratories, Inc. · 1994

All 62 as Advanced Technology Laboratories, Inc. →