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FDA 510(k)

POINT 500 HD POINT500C HD

K-Number: K121800 · 2013-01-24

ApplicantPointnix Co., Ltd.
Decision Date2013-01-24
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

POINT 500 HD POINT500C HD is the device name listed in this FDA 510(k) record. The listed applicant is Pointnix Co., Ltd.. It received FDA 510(k) clearance on 2013-01-24 under 510(k) number K121800. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POINT 500 HD POINT500C HD?

POINT 500 HD POINT500C HD is a medical device that received FDA 510(k) clearance on 2013-01-24. The listed applicant is Pointnix Co., Ltd.. The 510(k) number is K121800.

When did POINT 500 HD POINT500C HD receive FDA 510(k) clearance?

POINT 500 HD POINT500C HD received FDA 510(k) clearance on 2013-01-24, under 510(k) number K121800.

Who is the listed applicant for POINT 500 HD POINT500C HD?

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

What is the FDA product code for POINT 500 HD POINT500C HD?

The FDA product code for POINT 500 HD POINT500C HD is MUH.

Related Clinical Trials

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.

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Other records listing Pointnix 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.

K222738Point implant system

Related Devices (Code: MUH)

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.

K251793SOTA Cloud Smart Sensor (1.5)Sota Cloud Corp.K252570EzSensor HD, EzSensor UHDQpix Solutions, Inc.K250687Cocoon Solo (DX-7020s)Dexcowin Global, Inc.K251206Digital X-Ray DentiMax Pro Imaging SystemDentimax, Inc.K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)VATECH Co., Ltd.K242778X Sensor (Model: IOS-A15IF, HDI-15DGF)Qpix Solutions, Inc.

Official Source

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

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