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FDA 510(k)

SUNIRAY II DIGITAL RADIOGRAPHY SYSTEM

K-Number: K070219 · 2007-02-07

ApplicantSuni Medical Imaging, Inc.
Decision Date2007-02-07
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SUNIRAY II DIGITAL RADIOGRAPHY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Suni Medical Imaging, Inc.. It received FDA 510(k) clearance on 2007-02-07 under 510(k) number K070219. 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 SUNIRAY II DIGITAL RADIOGRAPHY SYSTEM?

SUNIRAY II DIGITAL RADIOGRAPHY SYSTEM is a medical device that received FDA 510(k) clearance on 2007-02-07. The listed applicant is Suni Medical Imaging, Inc.. The 510(k) number is K070219.

When did SUNIRAY II DIGITAL RADIOGRAPHY SYSTEM receive FDA 510(k) clearance?

SUNIRAY II DIGITAL RADIOGRAPHY SYSTEM received FDA 510(k) clearance on 2007-02-07, under 510(k) number K070219.

Who is the listed applicant for SUNIRAY II DIGITAL RADIOGRAPHY SYSTEM?

The FDA 510(k) record lists Suni Medical Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUNIRAY II DIGITAL RADIOGRAPHY SYSTEM?

The FDA product code for SUNIRAY II DIGITAL RADIOGRAPHY SYSTEM is MUH.

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Other records listing Suni Medical Imaging, Inc. 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.

K162585SuniIQ Digital Radiography SystemK083917X-RAY, TOMOGRAPHY, COMPUTED, DENTALK060149SUNIPAN IMAGING SYSTEM & ACCESSORIES

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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