Skip to content

Novus Image Archive System, Teleradiology System

by Novus Technologies, Inc. 510(k)

Active United States

510(k) K931410

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK931410 Date18 Feb 1994ClearedStatusActive

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  • Withdrawn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 12 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LMB
Device Class
Class I
Regulation
21 CFR Part 892.2010
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent