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Model 410SI-64 Shoulder Loop Pair, Small & Large, Nidek 410SI-42A Shoulder Loop Pair, Small & Large

by Medical Advances, Inc.

510(k) K950966

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK950966 Date26 Jul 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Model 410SI-64 Shoulder Loop Pair, Small & Largem Nidek 410SI-42A Shoulder Loop Pair, Small & Large
510(k) Number
FDA Product Code
MOS
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Model 410si-64 Shoulder Loop Pair, Small & Large, Nidek 410si-42a Shoulder Loop Pair, Small & Large is a Coil, Magnetic Resonance, Specialty device. It is used in the field of Radiology.

The device is supplied in sizes Small and Large. It has been cleared under the FDA 510K clearance with the K-number K950966. The device is classified as a Class II device with the regulation number 892.1000.

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Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Model 410si-64 Shoulder Loop Pair used for?

    The Model 410si-64 Shoulder Loop Pair is used in the field of Radiology as a Magnetic Resonance Coil.

  • What sizes is the Model 410si-64 Shoulder Loop Pair supplied in?

    The device is supplied in sizes Small and Large.

  • Is the Model 410si-64 Shoulder Loop Pair cleared by the FDA?

    Yes, the device has been cleared under the FDA 510K clearance with the K-number K950966.