510(k) Report

FDA applicant

Adr Ultrasound

Mchenry, IL10 decisions1980–19840 recalls

FDA records 10 decisions for Adr Ultrasound (Mchenry, IL) from 1980 to 1984: 10 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and ITX (Transducer, Ultrasonic, Diagnostic). 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 Adr Ultrasound’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Adr Ultrasound since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Adr Ultrasound 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, Ultrasonic4decisions
  • ITXTransducer, Ultrasonic, Diagnostic2decisions

What has FDA decided for it lately?

  • K840408Linear Array Transducer or ScanheadAdr Ultrasound · 1984
  • K834141Ultrasound Scan Head 3.5 MHZAdr Ultrasound · 1984
  • K833224Bifocal 3.0MHZAdr Ultrasound · 1983
  • K828049Adr Ultrasound MC2 Large CartAdr Ultrasound · 1982
  • K828051Adr Ultrasound Model 4000 SC or 4000 S/LCAdr Ultrasound · 1982
  • K828053Adr Ultrasound 5.5 MHZ Short Focus TransducerAdr Ultrasound · 1982
  • K828050Adr Ultrasound Model 4000 LAdr Ultrasound · 1982
  • K813543Adr Ultrasound Models 4000S & 4000S/LAdr Ultrasound · 1982

All 10 as Adr Ultrasound →