Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

INTRABEAM 600

K-Number: K162568 · 2016-12-15

ApplicantCarl Zeiss Meditec, AG
Decision Date2016-12-15
Product CodeJAD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INTRABEAM 600 is a medical device manufactured by Carl Zeiss Meditec, AG. It received FDA 510(k) clearance on 2016-12-15 under approval number K162568. The device is classified under product code JAD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRABEAM 600?

INTRABEAM 600 is a medical device that received FDA 510(k) clearance on 2016-12-15. It is manufactured by Carl Zeiss Meditec, AG. The 510(k) number is K162568.

When was INTRABEAM 600 approved by the FDA?

INTRABEAM 600 received FDA 510(k) clearance on 2016-12-15, under approval number K162568.

What company makes INTRABEAM 600?

INTRABEAM 600 is manufactured by Carl Zeiss Meditec, AG.

What is the FDA product code for INTRABEAM 600?

The FDA product code for INTRABEAM 600 is JAD.

Other Devices by Carl Zeiss Meditec, AG

K170667QEVO System with KINEVO 900 K162991YELLOW 560 Fluorescence Module K170638Retina Workplace K162684SL 220 K170171IOLMaster 700 K161607VISULUX

View all 26 devices →

Related Devices (Code: JAD)

K153570Axxent Electronic Brachytherapy System Model 110 XP 1200Icad, Inc. K172080Photoelectric Therapy SystemXstrahl, Ltd. K173425SRT-100+Sensus Healthcare, Inc. K190255Sensus Healthcare TVM Balloon ApplicatorSensus Healthcare, Inc. K182641Sensus IORT SystemSensus Healthcare, Inc. K213942EsteyaNucletron B.V.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑