510(k) Report

FDA applicant

Insight Neuroimaging Systems, LLC

Worchester, MA1 decision2006–20060 recalls

FDA records 1 decision for Insight Neuroimaging Systems, LLC (Worchester, MA) in 2006: 1 510(k) clearance. All are in product code MOS (Coil, Magnetic Resonance, Specialty). Its devices cite 3 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 Insight Neuroimaging Systems, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Insight Neuroimaging Systems, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Insight Neuroimaging Systems, LLC 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?

  • MOSCoil, Magnetic Resonance, Specialty1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K061281Insight Head CoilInsight Neuroimaging Systems, LLC · 2006

The one decision as Insight Neuroimaging Systems, LLC →

Other applicant names beginning “Insight”

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

Insight Medical Corp. 3Insight International, Inc. 2Insight Technologies Instruments, LLC 2Insight Medical Systems, Inc. 2Insight Systems 1Insight Optical Mfg. Co. of Florida, Inc. 1Insight Dental System 1Insight Instruments Mfg., Inc. 1Insight Instruments, Inc. 1Insight Medbotics, Inc. 1