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Belmont Podiatry Model 065 X-Ray

by Belmont Equipment Corp.

510(k) K811142

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 NumberK811142 Date9 Jun 1981ClearedStatusActive

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  • Withdrawn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
KPR
Device Class
Class II
Regulation
21 CFR Part 892.1680
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.

This device is a stationary X-ray system classified under the radiology medical specialty. It is a Class II medical device that received FDA 510(k) clearance as substantially equivalent to a predicate device.

It was cleared under regulation number 892.1680 with product code KPR. The device was manufactured by Belmont Equipment Corp., with the 510(k) submission received on April 27, 1981, and a decision issued on June 9, 1981, under K-number K811142.

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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 Belmont Podiatry Model 065 X-Ray used for?

    This device is a stationary X-ray system intended for use in radiology to produce diagnostic images of the foot and ankle in podiatric applications, as indicated by its device name and classification under radiology specialty.

  • How is the Belmont Podiatry Model 065 X-Ray supplied and installed?

    It is a stationary system, meaning it is designed for fixed installation in a clinical setting and is not portable; it requires professional installation and connection to power and imaging infrastructure as a fixed radiographic unit.

  • Is the Belmont Podiatry Model 065 X-Ray reusable or single-use?

    As a stationary X-ray system composed of durable components like an X-ray tube, collimator, and control console, it is intended for repeated use over many years with proper maintenance, not for single-use disposal.