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)

PACS CORE/ENCORE

K-Number: K161518 · 2016-08-17

ApplicantCompania Mexicana DE Radiologia Cgr, S.A. DE C.V.
Decision Date2016-08-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PACS CORE/ENCORE is a medical device manufactured by Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.. It received FDA 510(k) clearance on 2016-08-17 under approval number K161518. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PACS CORE/ENCORE?

PACS CORE/ENCORE is a medical device that received FDA 510(k) clearance on 2016-08-17. It is manufactured by Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.. The 510(k) number is K161518.

When was PACS CORE/ENCORE approved by the FDA?

PACS CORE/ENCORE received FDA 510(k) clearance on 2016-08-17, under approval number K161518.

What company makes PACS CORE/ENCORE?

PACS CORE/ENCORE is manufactured by Compania Mexicana DE Radiologia Cgr, S.A. DE C.V..

What is the FDA product code for PACS CORE/ENCORE?

The FDA product code for PACS CORE/ENCORE is LLZ.

Other Devices by Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.

K182134ARiX RAD Radiographic System K193637MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System

Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, LLC

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.

↑