Name: Predicase
Price: 199 USD

K-number	K161368
Device name	DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)
Applicant	Agfa Healthcare N.V.
Product code	MQB
Device class	Class II
Decision date	Sep 22, 2016
Decision	Substantially Equivalent
Regulation	892.1680

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

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

Everything you need for a 510(k) submission. Nothing you don't.