Skip to content

Accurad-200 System & Accurad-300 Plus System

by Denar Corp. 510(k)

Active United States

510(k) K925705

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK925705 Date28 Dec 1992ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
IWY
Device Class
Class I
Regulation
21 CFR Part 892.1920
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Denar Corp.