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FDA 510(k)

MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES)

K-Number: K011111 · 2001-05-30

ApplicantModular X-Ray Devices
Decision Date2001-05-30
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES) is the device name listed in this FDA 510(k) record. The listed applicant is Modular X-Ray Devices. It received FDA 510(k) clearance on 2001-05-30 under 510(k) number K011111. 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 MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES)?

MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES) is a medical device that received FDA 510(k) clearance on 2001-05-30. The listed applicant is Modular X-Ray Devices. The 510(k) number is K011111.

When did MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES) receive FDA 510(k) clearance?

MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES) received FDA 510(k) clearance on 2001-05-30, under 510(k) number K011111.

Who is the listed applicant for MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES)?

The FDA 510(k) record lists Modular X-Ray Devices as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES)?

The FDA product code for MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES) 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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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