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Jpi Automatic X-Ray Film Processor

FDA 510(k)

Class II (US FDA 510(k))

510(k) K955706

by Jpi Healthcare. Co., Ltd.

Identifiers

510(k) Number
K955706 FDA 510(k)
FDA Product Code
IXW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1900 FDA 510(k)
Regulation Number
892.1900 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Jpi Automatic X-Ray Film Processor by Jpi Healthcare. Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

FDA Applicant
Jpi Healthcare Co, Ltd.

Sources (1)

  • FDA 510(k) K955706 24 fields · synced Jun 18, 2026