Name: Predicase
Price: 199 USD

K-number	K170816
Device name	Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM
Applicant	Brainlab AG
Product code	LLZ
Device class	Class II
Decision date	Sep 26, 2017
Decision	Substantially Equivalent
Regulation	892.2050

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 →

Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM

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