510(k) Report

FDA applicant

Computer Design & Applications, Inc.

Waltham, MA3 decisions1983–19840 recalls

FDA records 3 decisions for Computer Design & Applications, Inc. (Waltham, MA) from 1983 to 1984: 3 510(k) clearances. All are in product code IYX (Camera, Scintillation (Gamma)). 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 Computer Design & Applications, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Computer Design & Applications, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Computer Design & Applications, 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?

  • IYXCamera, Scintillation (Gamma)2decisions

What has FDA decided for it lately?

  • K843558Deltanode, Mega Delta, Delta Link-Computer Design & Applications, Inc. · 1984
  • K841964Micro Delta & CeltaproComputer Design & Applications, Inc. · 1984
  • K837213Multi-User Imaging and Acquisition TerminalsComputer Design & Applications, Inc. · 1983

All 3 as Computer Design & Applications, Inc. →

Other applicant names beginning “Computer”

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

Computer Motion, Inc. 26Computer Dialysis Systems, Inc. 4Computer Programs and Systems, Inc. 1Computer Sports Medicine, Inc. 1