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

FDA 510(k)

Prizma

K-Number: K170181 · 2017-09-01

ApplicantG-Medical Innovations , Ltd.
Decision Date2017-09-01
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Prizma is the device name listed in this FDA 510(k) record. The listed applicant is G-Medical Innovations , Ltd.. It received FDA 510(k) clearance on 2017-09-01 under 510(k) number K170181. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Prizma?

Prizma is a medical device that received FDA 510(k) clearance on 2017-09-01. The listed applicant is G-Medical Innovations , Ltd.. The 510(k) number is K170181.

When did Prizma receive FDA 510(k) clearance?

Prizma received FDA 510(k) clearance on 2017-09-01, under 510(k) number K170181.

Who is the listed applicant for Prizma?

The FDA 510(k) record lists G-Medical Innovations , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prizma?

The FDA product code for Prizma is DXH. This falls under the Hematology category.

Other records listing G-Medical Innovations , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K173589Prizma

Related Devices (Code: DXH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250233PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.)K250258HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemHeartbeam, Inc.K243438MEMO Patch M (MPT-E08R-UNC01)Huinno Co., Ltd.K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.K243003VitalSigns 1-Lead Holter (VSH101)VitalSigns Technology Co., Ltd.K233521QT ECG (QTERD100)QT Medical, Inc.

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.

↑