DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)

by Agfa Healthcare N.V. 510(k)

Active United States

510(k) K161368

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK161368	Date22 Sep 2016Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k)

510(k) Number: K161368
FDA Product Code: MQB

Device Class: Class II
Regulation: 21 CFR Part 892.1680
Advisory Committee: Radiology
FDA Decision: SESE Substantially Equivalent

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