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Box for radiographic Grid-1000(for connection(outside 1394mmx495mm))

FDA UDI

Class I (US FDA UDI)

by Jpi Healthcare, Inc.

Identity

Trade Name
Box for radiographic Grid-1000(for connection(outside 1394mmx495mm)) FDA UDI
Generic Name
Stationary x-ray grid FDA UDI
Device Name
A component of an x-ray system used in diagnostic x-ray imaging applications, e.g., planar x-ray imaging. It typically consists of a housing containing lead foil strips separated by x-ray transparent spacers. These spacers or "interspaces" are filled with aluminium (Al) or another x-ray transparent (radiolucent) organic compound. Radiographic grids are placed between the x-ray target (patient) and the x-ray film and are used to absorb scatter radiation, and improve radiographic image contrast. It typically comes in two patterns, linear and crossed. Most are focused to a line in space called a convergent line, but can be used over a variable range called the focal distance. FDA UDI
Model / Reference
Grid-1000 FDA UDI
Description
A component of an x-ray system used in diagnostic x-ray imaging applications, e.g., planar x-ray imaging. It typically consists of a housing containing lead foil strips separated by x-ray transparent spacers. These spacers or "interspaces" are filled with aluminium (Al) or another x-ray transparent (radiolucent) organic compound. Radiographic grids are placed between the x-ray target (patient) and the x-ray film and are used to absorb scatter radiation, and improve radiographic image contrast. It typically comes in two patterns, linear and crossed. Most are focused to a line in space called a convergent line, but can be used over a variable range called the focal distance. FDA UDI

Identifiers

Primary DI / UDI-DI
08809413810457 FDA UDI
510(k) Number
K945327 FDA UDI
FDA Product Code
IXJ FDA UDI
GMDN Term
Stationary x-ray grid FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
892.1910 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Stationary x-ray grid

Box for radiographic Grid-1000(for connection(outside 1394mmx495mm)) by Jpi Healthcare, Inc. — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Stationary x-ray grid.

Cleared under the same submission

K945327 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Jpi Healthcare, Inc.

Sources (1)

  • FDA UDI ef7b1a62-f060-42e7-b208-2cc6a9cc806c 35 fields · synced May 30, 2026