510(k) Report

FDA applicant

Miles Inc., Agfa Division

Ridgefield Park, NJ2 decisions1994–19950 recalls

FDA records 2 decisions for Miles Inc., Agfa Division (Ridgefield Park, NJ) from 1994 to 1995: 2 510(k) clearances. Most are in product codes IYX (Camera, Scintillation (Gamma)) and JAC (System, X-Ray, Film Marking, 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 Miles Inc., Agfa Division’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Miles Inc., Agfa Division since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Miles Inc., Agfa Division 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)1decision
  • JACSystem, X-Ray, Film Marking, Radiographic1decision

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.

  • K943602DI-2000Miles Inc., Agfa Division · 19951cites it

What has FDA decided for it lately?

  • K943602DI-2000Miles Inc., Agfa Division · 1995
  • K942883Digital I.D. CameraMiles Inc., Agfa Division · 1994

All 2 as Miles Inc., Agfa Division →

Other applicant names beginning “Miles”

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

Miles Laboratories, Inc. 159Miles, Inc. 11Miles Pharmaceuticals 2Miles Inc., Dental Products 2Miles Diagnostics Div. 1