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Slices

by Microsignal Corp.

510(k) K941812

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 NumberK941812 Date12 Aug 1994ClearedStatusActive

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  • Withdrawn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)

510(k) Number
FDA Product Code
LNH
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 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 Slices is a System, Nuclear Magnetic Resonance Imaging device, designed for MRI applications. It functions as a specialized component within magnetic resonance imaging systems, contributing to the acquisition and processing of imaging data for diagnostic purposes in radiology.

This device is intended for use in MRI-compatible environments and is classified under product code LNH. It is supplied as a reusable system component, adhering to regulatory standards outlined under 892.1000. The Slices received FDA 510(k) clearance (K941812) under the Traditional pathway, with a decision of Substantially Equivalent, as reviewed by the Radiology (RA) Advisory Committee in 1994.

Questions

AI-generated answers, 20 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 primary purpose of the Slices device in an MRI environment?

    The Slices is a specialized component designed to enhance the performance of magnetic resonance imaging (MRI) systems by contributing to the acquisition and processing of imaging data. It is intended to improve diagnostic imaging quality within MRI-compatible environments, specifically for use in radiology.

  • Is the Slices device reusable or single-use, and how should it be maintained?

    The Slices is supplied as a reusable system component, meaning it is designed for repeated use within MRI systems. Since it is reusable, proper maintenance and cleaning protocols must be followed to ensure consistent performance and compliance with regulatory standards outlined under 892.1000.

  • What regulatory pathway was followed for FDA clearance of the Slices, and what does that mean for its use?

    The Slices received FDA 510(k) clearance under the Traditional pathway, determined to be *substantially equivalent* to a legally marketed predicate device. This means it was reviewed by the FDA’s Radiology (RA) Advisory Committee in 1994 and deemed suitable for its intended use in MRI systems, adhering to established safety and performance standards.

  • How many unique registration numbers are associated with the Slices device?

    The Slices device is linked to 50+ unique registration numbers (listed in the OpenFDA dataset), reflecting its compatibility with multiple MRI system configurations or models. These identifiers are used for tracking and regulatory purposes but do not indicate separate devices or variations in function.

  • What medical specialty is primarily responsible for utilizing the Slices device?

    The Slices is classified under the Radiology medical specialty, meaning it is intended for use by radiologists, radiologic technologists, and other imaging specialists who rely on MRI systems for diagnostic purposes.