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Portaray Unit, X-Ray, Intraoral

by Siemens Corp.

510(k) K792535

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 NumberK792535 Date28 Jan 1980ClearedStatusActive

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  • Withdrawn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)

Full name
Portaray
510(k) Number
FDA Product Code
EAP
Device Class
Class II
Regulation
21 CFR Part 872.1810
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Portaray is classified as an Intraoral X-Ray Unit, designed for dental radiography. It produces radiographic images of the teeth and surrounding structures to aid in the diagnosis of dental conditions, including caries, periodontal disease, and developmental abnormalities.

This device is supplied as a standalone intraoral X-ray system, intended for use in dental offices and clinics. It is regulated under FDA 510(k) clearance (K792535) and falls under Class II medical devices (product code EAP). The system is non-sterile, reusable, and intended for single-patient use per session, with no specific MRI safety restrictions noted.

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