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Flurospot H Version 2

by Siemens Medical Solutions USA, Inc.

510(k) K914525

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 NumberK914525 Date19 Nov 1991ClearedStatusActive

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  • Withdrawn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
JAA
Device class
Class II
Regulation
21 CFR Part 892.1650
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Fluorspot H Version 2 is a PC-based, 10-bit acquisition digital imaging system where images are acquired in 1024x1024 matrix format. It is classified as a System, X-Ray, Fluoroscopic, Image-Intensified under FDA device classification.

It received FDA 510(k) clearance (K914525) on November 19, 1991, as substantially equivalent to a predicate device. The device is intended for use in radiology and is manufactured by Siemens Medical Solutions USA, Inc. in Iselin, New Jersey.

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