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FDA 510(k)

CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM

K-Number: K101779 · 2011-05-16

ApplicantJpi Healthcare Co, Ltd.
Decision Date2011-05-16
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Jpi Healthcare Co, Ltd.. It received FDA 510(k) clearance on 2011-05-16 under 510(k) number K101779. 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 CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM?

CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 2011-05-16. The listed applicant is Jpi Healthcare Co, Ltd.. The 510(k) number is K101779.

When did CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM receive FDA 510(k) clearance?

CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM received FDA 510(k) clearance on 2011-05-16, under 510(k) number K101779.

Who is the listed applicant for CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM?

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

What is the FDA product code for CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM?

The FDA product code for CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM is KPR.

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Other records listing Jpi Healthcare 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.

K260482DRE DuoK244010ExamVue ApexK213057ExamVue DuoK102327CLEARVISION DR 7000FK955706JPI AUTOMATIC X-RAY FILM PROCESSORK954161JPI INTENSIFYING SCREEN

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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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