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Deltamanager

by Medimage, Inc.

510(k) K933321

Deltamanager is a Class II device made by Medimage, Inc., cleared under FDA 510(k) K933321 on 3 Nov 1993, 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 · Traditional NumberK933321 Date3 Nov 1993ClearedStatusActive

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  • Withdrawn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
KPS
Device class
Class II
Regulation
21 CFR Part 892.1200
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Devices cleared under K933321

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K933321
UDI-DISize and differences
DELTAmanager 12
Medimage, Inc.
1200861333000309 —On the market

Similar devices

Other devices filed under FDA product code KPS (System, Tomography, Computed, Emission).

Other devices from Medimage, Inc.

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