510(k) Report

FDA applicant

Diagnostic Medical Systems

La Jolla, CA2 decisions2000–20010 recalls

FDA records 2 decisions for Diagnostic Medical Systems (La Jolla, CA) from 2000 to 2001: 1 510(k) clearance and 1 original PMA approval. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and MUA (Bone Sonometer). Its devices cite 5 predicates, 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 Diagnostic Medical Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Diagnostic Medical Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Diagnostic Medical Systems 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?

  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic1decision
  • MUABone Sonometer1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K990517Explorer CVS Transcranial DopplerDiagnostic Medical Systems · 20001cites it

What has FDA decided for it lately?

  • P000055Ubis 5000 Bone SonometerDiagnostic Medical Systems · 2001
  • K990517Explorer CVS Transcranial DopplerDiagnostic Medical Systems · 2000

All 2 as Diagnostic Medical Systems →

Other applicant names beginning “Diagnostic”

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

Diagnostic Products Corp. 324Diagnostic Systems Laboratories, Inc. 94Diagnostic Chemicals, Ltd. (Usa) 77Diagnostic Reagents, Inc. 66Diagnostic Chemicals, Ltd. 66Diagnostic Hybrids, Inc. 37Diagnostic Technology, Inc. 28Diagnostic Solutions, Inc. 26Diagnostic Ultrasound Corp. 16Diagnostic Systems 14Diagnostic Reagent Tech. 10Diagnostic Specialties 8