Name: Predicase
Price: 199 USD

K-number	K171207
Device name	FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M
Applicant	Fujifilm Medical Systems U.S.A, Inc.
Product code	ODG
Device class	Class II
Decision date	Jan 11, 2018
Decision	Substantially Equivalent
Regulation	876.1500

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 →

FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M

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