510(k) Report

FDA applicant

Volumetrics Medical Imaging, Inc.

Durham, NC2 decisions1998–19990 recalls

FDA records 2 decisions for Volumetrics Medical Imaging, Inc. (Durham, NC) from 1998 to 1999: 2 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Its devices cite 2 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 Volumetrics Medical Imaging, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Volumetrics Medical Imaging, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Volumetrics Medical Imaging, 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, Ultrasonic1decision
  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K992378Diagnostic Ultrasound, Model 1.0Volumetrics Medical Imaging, Inc. · 1999
  • K982498Diagnostic Ultrasound SystemVolumetrics Medical Imaging, Inc. · 1998

All 2 as Volumetrics Medical Imaging, Inc. →