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FDA 510(k)

DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)

K-Number: K131314 · 2013-06-25

ApplicantSwissray Medical AG
Decision Date2013-06-25
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is Swissray Medical AG. It received FDA 510(k) clearance on 2013-06-25 under 510(k) number K131314. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)?

DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM) is a medical device that received FDA 510(k) clearance on 2013-06-25. The listed applicant is Swissray Medical AG. The 510(k) number is K131314.

When did DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM) receive FDA 510(k) clearance?

DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM) received FDA 510(k) clearance on 2013-06-25, under 510(k) number K131314.

Who is the listed applicant for DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)?

The FDA 510(k) record lists Swissray Medical AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)?

The FDA product code for DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM) is MQB.

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Other records listing Swissray Medical AG 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.

K123005DDRVERSA MOTIONK110828DDRELEMENTK052943DDRFORMULA AND DDRFORMULA PLUS

Related Devices (Code: MQB)

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.

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, 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.

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