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Jpi Healthcare, Inc.

US

Last updated May 24, 2026

Part of Jpi Healthcare. Co., Ltd.

What Jpi Healthcare, Inc. makes

Jpi Healthcare, Inc. manufactures stationary x-ray grids for radiographic imaging, including various boxed configurations for different applications such as Grid-1000 series models. Their product line also includes manual x-ray film cassettes, automated darkroom processors for developing x-ray film, indirect flat panel x-ray detectors, and basic diagnostic x-ray system software. Examples include specialized grid boxes for high-line and connection setups, as well as cassettes like the Radiographic Film Cassette and ExamVue systems.

The company’s devices are regulated under FDA classifications, with most falling into Class I and Class II categories. These products are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries, ensuring compliance with U.S. medical device regulations. The manufacturer operates from the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Jpi Healthcare, Inc. manufacture?

Jpi Healthcare, Inc. specializes in radiographic imaging equipment and accessories. Their product line includes stationary x-ray grids (such as the Grid-1000 series in various boxed configurations), manual x-ray film cassettes (e.g., Radiographic Film Cassette), automated darkroom processors for developing x-ray film, indirect flat panel x-ray detectors, and basic diagnostic x-ray system software (like ExamVue). These devices support traditional and digital radiographic workflows.

Where is Jpi Healthcare, Inc. based, and how does that affect their regulatory compliance?

Jpi Healthcare, Inc. is based in the United States, which means their devices are subject to U.S. regulatory requirements, including those enforced by the FDA. Since their products are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries, they comply with mandatory U.S. medical device regulations. The company’s location ensures alignment with FDA classification standards, where most of their devices fall under Class I or Class II.

Which regulatory registries list Jpi Healthcare, Inc.’s devices, and why does this matter?

Jpi Healthcare, Inc.’s devices are listed in the FDA’s 510(k) premarket notification registry and the Unique Device Identifier (UDI) database. Inclusion in these registries demonstrates compliance with U.S. requirements for medical device authorization. The 510(k) process ensures devices meet safety and effectiveness standards by demonstrating substantial equivalence to existing approved products, while UDIs enable better tracking, traceability, and regulatory oversight throughout the device lifecycle.

How are Jpi Healthcare, Inc.’s devices classified under FDA regulations?

Jpi Healthcare, Inc.’s devices are classified under the FDA’s medical device classification system as either Class I or Class II. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional premarket notification (510(k)) clearance to ensure their safety and performance. The classification depends on factors like the device’s intended use, potential risks, and the body system it interacts with, as outlined in FDA regulations.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
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Catalogue (46)

DeviceModel / ReferenceRegistriesClassStatus
Box for radiographic Grid-1000((G-1(outside 620mmx180mmx610mm)) Grid-1000
FDA UDI
Class IActive
Box for radiographic Grid-1000(for High Line(outside 569mmx539mm)) Grid-1000
FDA UDI
Class IActive
Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm), packing quantity:1) Grid-1000
FDA UDI
Class IActive
ExamVue ExamVue PACS
FDA UDI
Class IIActive
Box for radiographic Grid-1000(for connection(outside 962mmx495mm)) Grid-1000
FDA UDI
Class IActive
Box for radiographic Grid-1000(15"x18"(outside 523mmx481mm) Grid-1000
FDA UDI
Class IActive
Radiographic Film Cassette G/AFAB TYPE
FDA UDI
Class IIActive
Box for radiographic Grid-1000(9"x11"(outside 345mmx329mm)) Grid-1000
FDA UDI
Class IActive
Box for ExamVue DR(outside 265mmx185mmx150mm) ExamVue DR
FDA UDI
Class IIActive
Box for radiographic Grid-1000(New out box-5(outside 1190mmx850mmx610mm)) Grid-1000
FDA UDI
Class IActive
Box for radiographic Grid-1000(for SSME(outside 330mmx375mm)) Grid-1000
FDA UDI
Class IActive
Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm), packing quantity:9) Grid-1000
FDA UDI
Class IActive
Box for radiographic Grid-1000(P-20(outside 1440mmx340mmx590mm)) Grid-1000
FDA UDI
Class IActive
Box for radiographic Grid-1000(P-10(outside 1440mmx340mmx590mm)) Grid-1000
FDA UDI
Class IActive
Box for radiographic Grid-1000(New out box-1(outside 620mmx250mmx610mm)) Grid-1000
FDA UDI
Class IActive
ExamVue ExamVue DR
FDA UDI
Class IIActive
Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm), packing quantity:8) Grid-1000
FDA UDI
Class IActive
Box for ExamVue PACS(outside 265mmx185mmx150mm) ExamVue PACS
FDA UDI
Class IIActive
Box for radiographic Grid-1000(11"x13"(outside 395mmx380mm)) Grid-1000
FDA UDI
Class IActive
Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm), packing quantity:3) Grid-1000
FDA UDI
Class IActive
Box for radiographic Grid-1000(18"x18"(outside 525mmx560mm)) Grid-1000
FDA UDI
Class IActive
Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm), packing quantity:6) Grid-1000
FDA UDI
Class IActive
Box for radiographic Grid-1000(P-5(outside 1440mmx190mmx160mm)) Grid-1000
FDA UDI
Class IActive
Box for radiographic Grid-1000(for SSME(outside 569mmx539mm & thickness 38mm)) Grid-1000
FDA UDI
Class IActive
Box for radiographic Grid-1000(New out box-3(outside 620mmx670mmx610mm)) Grid-1000
FDA UDI
Class IActive
Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm), packing quantity:2) Grid-1000
FDA UDI
Class IActive
Radiographic Film Cassette AFAB TYPE
FDA UDI
Class IIActive
Box for radiographic Grid-1000(for connection(outside 1394mmx495mm)) Grid-1000
FDA UDI
Class IActive
Automatic Radiographic Film Processor JP-33
FDA UDI
Class IIActive
Box for radiographic Grid-1000(New out box-4(outside 1050mmx620mmx610mm)) Grid-1000
FDA UDI
Class IActive
Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm), packing quantity:4) Grid-1000
FDA UDI
Class IActive
Radiographic Film Cassette AFAB-W TYPE
FDA UDI
Class IIActive
Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm), packing quantity:5) Grid-1000
FDA UDI
Class IActive
ClearVision ExamVue Flat Panel Detector ClearVision ExamVue Flat Panel Detector
FDA UDI
Class IIActive
Box for radiographic Grid-1000(P-30(outside 1440mmx890mmx590mm)) Grid-1000
FDA UDI
Class IActive
Radiographic Film Cassette G/AFAB-W TYPE
FDA UDI
Class IIActive
Box for radiographic Grid-1000(G5(outside620mmx140mmx590mm), packing quantity:10) Grid-1000
FDA UDI
Class IActive
Box for radiographic Grid-1000(P-10(outside 1440mmx190mmx160mm)) Grid-1000
FDA UDI
Class IActive
Box for radiographic Grid-1000(P-15 (outside 1440mmx890mmx590mm)) Grid-1000
FDA UDI
Class IActive
Radiographic Film Cassette SFBP TYPE
FDA UDI
Class IIActive
Box for radiographic Grid-1000(New out box-2(outside 620mmx470mmx610mm)) Grid-1000
FDA UDI
Class IActive
Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm)) Grid-1000
FDA UDI
Class IActive
Box for radiographic Grid-1000(15"x15"(outside 446mmx481mm)) Grid-1000
FDA UDI
Class IActive
Radiographic Grid Grid-3000
FDA UDI
Class IActive
Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm), packing quantity:7) Grid-1000
FDA UDI
Class IActive
ClearVision ExamVue Flat Panel Detector K160143
FDA 510(k)
Class IIActive

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