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Valencia Skin Applicator Set, Model 189.701

by Nucletron Corporation

510(k) K073107

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 · Special NumberK073107 Date7 Dec 2007ClearedStatusActive

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  • Withdrawn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
JAQ
Device Class
Class II
Regulation
21 CFR Part 892.5700
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 Valencia Skin Applicator Set, model 189.701, is a remote-controlled radionuclide applicator system. It is designed for use in radiology applications.

This Class II medical device has received FDA 510(k) clearance under regulation number 892.5700. It is manufactured by Nucletron Corporation.

Other devices from Nucletron Corp.

See all devices from Nucletron 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 Valencia Skin Applicator Set used for?

    The Valencia Skin Applicator Set, model 189.701, is a remote-controlled radionuclide applicator system designed for use in radiology applications.

  • What is the regulatory status of the Valencia Skin Applicator Set?

    This device is classified as a Class II medical device and has received FDA 510(k) clearance under regulation number 892.5700.

  • Who is the manufacturer of this radionuclide applicator system?

    The Valencia Skin Applicator Set, model 189.701, is manufactured by Nucletron Corporation, based in Columbia, Maryland.