510(k) Report

FDA applicant

Phoenix Imaging

Tempe, AZ2 decisions1988–19890 recalls

FDA records 2 decisions for Phoenix Imaging (Tempe, AZ) from 1988 to 1989: 2 510(k) clearances. Most are in product codes DXK (Echocardiograph) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). 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, cardiovascular panel, where it files most

How often FDA has decided Phoenix Imaging’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Phoenix Imaging since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Phoenix Imaging’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DXKEchocardiograph1decision
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision

What has FDA decided for it lately?

  • K883845Resubmitted AI 5200 Ultrasound TransducerPhoenix Imaging · 1989
  • K880839AI 5200 Diagnostic Ultrasound SystemPhoenix Imaging · 1988

All 2 as Phoenix Imaging →

Other applicant names beginning “Phoenix”

FDA records each applicant name separately; these may or may not be the same firm.

Phoenix Diagnostics, Inc. 21Phoenix Biomedical Corp. 13Phoenix Medical Technology, Inc. 11Phoenix Glove Co. 6Phoenix Dental, Inc. 5Phoenix Bioengineering, Inc. 3Phoenix Medical Devices, LLC 2Phoenix Innovative Healthcare Manufacturers Pvt., Ltd. 2Phoenix Biotech Corp. 2Phoenix Surgical Products, Inc. 1Phoenix Management, Inc. 1Phoenix U.V.A., Ltd. 1