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Csp-a Ceiling Suspended Positioner-angio

by Fischer Imaging Corp.

510(k) K924137

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 NumberK924137 Date28 Dec 1992ClearedStatusActive

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  • Withdrawn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
IZI
Device Class
Class II
Regulation
21 CFR Part 892.1600
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 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 Ceiling Suspended Positioner-Angio is an angiographic X-ray system designed for use in radiology. It functions as a positioner to support and orient imaging equipment during diagnostic procedures.

This device is classified as a Class II medical device and received FDA 510(k) clearance under K924137 in 1992. It is manufactured by Fischer Imaging Corp. and is intended for use within a clinical radiology setting.

Other devices from Fischer Imaging Corp.

See all devices from Fischer Imaging Corp. →

Questions

AI-generated answers, 6 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 is the primary purpose of the CSP-A?

    The CSP-A is an angiographic X-ray system designed for use in clinical radiology settings. Its primary function is to serve as a positioner that supports and orients imaging equipment during diagnostic procedures.

  • What is the regulatory status of the CSP-A?

    The CSP-A is classified as a Class II medical device. It received FDA 510(k) clearance under the number K924137 in 1992.

  • Who is the manufacturer of the CSP-A?

    The device is manufactured by Fischer Imaging Corp., which is based in Denver, Colorado.