510(k) Report

FDA applicant

Magna-Lab, Inc.

Newton, MA4 decisions1994–20020 recalls

FDA records 4 decisions for Magna-Lab, Inc. (Newton, MA) from 1994 to 2002: 4 510(k) clearances. Most are in product codes MOS (Coil, Magnetic Resonance, Specialty) and LNH (System, Nuclear Magnetic Resonance Imaging). Its devices cite 2 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Magna Lab, Inc.”.

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 Magna-Lab, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Magna-Lab, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Magna-Lab, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Magna-Lab, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Magna-Lab”

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