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IDS5 Image Display System

by Sectra AB

510(k) K001140

IDS5 Image Display System is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Sectra AB, cleared under FDA 510(k) K001140 on 3 May 2000, active as of 22 Oct 2026.

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK001140 Date3 May 2000ClearedStatusActive

Official records

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  • Withdrawn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

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

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