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QuantorView

by 3Disc Americas

510(k) K151687

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 NumberK151687 Date3 Aug 2015ClearedStatusActive

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  • Withdrawn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
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

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

QuantorView is a Class II X-ray system used in radiology. It is a computed radiography scanner designed for imaging applications.

The device received FDA 510(k) clearance (K151687) on August 3, 2015, and is manufactured by 3Disc Americas. It is supplied as a reusable system for use in clinical radiology settings.

Other devices from 3Disc Americas

Questions

AI-generated answers, 21 Sep 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 QuantorView used for?

    The QuantorView is a computed radiography scanner designed for imaging applications in clinical radiology settings, used to process imaging plates for diagnostic X-ray procedures.

  • Is the QuantorView a single-use or reusable device?

    The QuantorView is supplied as a reusable system, meaning it is designed for multiple uses in clinical environments after appropriate cleaning and maintenance between procedures.

  • Who manufactures the QuantorView and where are they located?

    The QuantorView is manufactured by 3Disc Americas, located at 22560 Glenn Dr. Suite 116, Sterling, VA 20164, United States.

  • What regulatory pathway was used for the QuantorView's market authorization?

    The QuantorView received market authorization through the FDA 510(k) pathway, specifically under submission K151687, which was cleared on August 3, 2015, as substantially equivalent to a legally marketed predicate device.