510(k) Report

FDA applicant

Independent Scintilation Imaging Systems, Inc.

Lachine Quebec, CA1 decision1994–19940 recalls

FDA records 1 decision for Independent Scintilation Imaging Systems, Inc. (Lachine Quebec, CA) in 1994: 1 510(k) clearance. All are in product code KPS (System, Tomography, Computed, Emission). 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 Independent Scintilation Imaging Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Independent Scintilation Imaging Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Independent Scintilation Imaging 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?

  • KPSSystem, Tomography, Computed, Emission1decision

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.

  • K940487Isocam II (Dual Head Gamma Camera)Independent Scintilation Imaging Systems, Inc. · 19941cites it

What has FDA decided for it lately?

  • K940487Isocam II (Dual Head Gamma Camera)Independent Scintilation Imaging Systems, Inc. · 1994

The one decision as Independent Scintilation Imaging Systems, Inc. →

Other applicant names beginning “Independent”

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

Independent Transfer Equipment Co. 2Independent Living, Inc. 1