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FDA 510(k)

Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM

K-Number: K102680 · 2010-10-22

ApplicantControl-X Medical, Inc.
Decision Date2010-10-22
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Control-X Medical, Inc.. It received FDA 510(k) clearance on 2010-10-22 under 510(k) number K102680. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM?

Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 2010-10-22. The listed applicant is Control-X Medical, Inc.. The 510(k) number is K102680.

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

Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM received FDA 510(k) clearance on 2010-10-22, under 510(k) number K102680.

Who is the listed applicant for Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM?

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

What is the FDA product code for Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM?

The FDA product code for Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM is KPR.

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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Related Devices (Code: KPR)

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.

K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50HDRTECH CorporationK260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream Health

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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