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FDA 510(k)

SONIC SHOT GX

K-Number: K091734 · 2010-05-21

ApplicantNemoto Kyorindo Co., Ltd.
Decision Date2010-05-21
Product CodeIZQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SONIC SHOT GX is the device name listed in this FDA 510(k) record. The listed applicant is Nemoto Kyorindo Co., Ltd.. It received FDA 510(k) clearance on 2010-05-21 under 510(k) number K091734. The device is classified under product code IZQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONIC SHOT GX?

SONIC SHOT GX is a medical device that received FDA 510(k) clearance on 2010-05-21. The listed applicant is Nemoto Kyorindo Co., Ltd.. The 510(k) number is K091734.

When did SONIC SHOT GX receive FDA 510(k) clearance?

SONIC SHOT GX received FDA 510(k) clearance on 2010-05-21, under 510(k) number K091734.

Who is the listed applicant for SONIC SHOT GX?

The FDA 510(k) record lists Nemoto Kyorindo Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SONIC SHOT GX?

The FDA product code for SONIC SHOT GX is IZQ.

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Other records listing Nemoto Kyorindo Co., 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.

K242212Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)K173450PRESS DUO elite, PRESS DUO elite AGK092896REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESSK071691DUAL SHOT ALPHAK062168CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHAK052633DUAL SHOT - CONTRAST DELIVERY SYSTEM

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Related Devices (Code: IZQ)

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.

K262115VueJect® Ultrasound Enhancing Agent Delivery SystemACIST Medical Systems, Inc.K252281ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KGK251295ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KGK252689MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)Imaxeon Pty, Ltd.K241849MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)Imaxeon Pty, Ltd.K241850ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KG

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.

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