510(k) Report

FDA applicant

Computerized Imaging Reference Systems, Inc.

Norfolk, VA2 decisions1985–19870 recalls

FDA records 2 decisions for Computerized Imaging Reference Systems, Inc. (Norfolk, VA) from 1985 to 1987: 2 510(k) clearances. Most are in product codes IXF (Test-Pattern, Radiographic) and IXG (Phantom, Anthropomorphic, Radiographic). 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 Computerized Imaging Reference Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Computerized Imaging Reference Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Computerized Imaging Reference Systems, 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?

  • IXFTest-Pattern, Radiographic1decision
  • IXGPhantom, Anthropomorphic, Radiographic1decision

What has FDA decided for it lately?

  • K865100Tissue-Equivalent Breast SimulatorComputerized Imaging Reference Systems, Inc. · 1987
  • K852528Bone Density CT PhantomComputerized Imaging Reference Systems, Inc. · 1985

All 2 as Computerized Imaging Reference Systems, Inc. →

Other applicant names beginning “Computerized”

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

Computerized Medical Systems, Inc. 23Computerized Screening, Inc. 2Computerized Anesthesia Systems, Inc. 1Computerized Functional Testing Corp. 1