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Kinematic Positioners

by GE Medical Systems, Inc.

510(k) K972704

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 NumberK972704 Date29 Sep 1997ClearedStatusActive

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  • Withdrawn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, 1 Oct 2026

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

The Kinematic Positioners are adjustable mechanical devices designed to secure and position patients during Nuclear Magnetic Resonance Imaging (MRI) scans. These systems provide precise, multi-axis control to ensure optimal alignment and stability of the patient’s body, enhancing image quality and reducing motion artifacts. They are specifically engineered for use with MRI-compatible systems, ensuring compatibility with magnetic fields and radiofrequency signals. The devices are categorized under Class II medical devices, indicating a higher level of regulatory oversight due to their role in diagnostic imaging.

These Kinematic Positioners are reusable and intended for use in radiology departments within MRI facilities. They must be cleaned and maintained according to manufacturer guidelines to ensure sterility and functionality. The devices are MRI-safe and are supplied as part of the Signa Profile Systems. They are authorized under FDA 510(k) clearance (K972704), with a clearance date of September 29, 1997, and are regulated under the regulation number 892.1000.

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Questions

AI-generated answers, 1 Oct 2026

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

  • What are the Kinematic Positioners used for?

    The Kinematic Positioners are designed to secure and position patients during Nuclear Magnetic Resonance Imaging (MRI) scans. They provide adjustable, multi-axis control to ensure optimal alignment and stability of the patient’s body, which helps improve image quality by minimizing motion artifacts. This is particularly important in radiology departments where accurate imaging is critical for diagnosis.

  • Are the Kinematic Positioners reusable or single-use?

    The Kinematic Positioners are reusable devices. They are intended for repeated use in MRI facilities, provided they are cleaned and maintained according to the manufacturer’s guidelines to ensure sterility and functionality. Proper maintenance is essential to preserve their performance and safety for ongoing use.

  • How are these devices supplied, and what systems do they integrate with?

    The Kinematic Positioners are supplied as part of the Signa Profile Systems by GE Medical Systems. They are specifically engineered to be MRI-compatible, ensuring they function safely within magnetic fields and radiofrequency signals used during MRI scans. This compatibility is critical for maintaining imaging accuracy and patient safety.

  • Do the Kinematic Positioners require any special storage or handling?

    While the device data does not specify detailed storage instructions, reusable medical devices like the Kinematic Positioners should be stored in a clean, dry environment to prevent contamination or damage. After each use, they must be thoroughly cleaned and maintained according to the manufacturer’s guidelines to ensure sterility and proper functionality. Proper storage also helps preserve their structural integrity for long-term use.

  • What regulatory pathway does the Kinematic Positioner follow?

    The Kinematic Positioners are classified as Class II medical devices under FDA regulations, indicating a higher level of oversight due to their role in diagnostic imaging. They were granted FDA 510(k) clearance (K972704) on September 29, 1997, under the regulation number 892.1000. This clearance confirms that the device is substantially equivalent to a legally marketed predicate device, ensuring it meets the necessary safety and effectiveness standards for use in MRI environments.