Identity
- Trade Name
- Radiographic Grid 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 or mammography. 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-3000 FDA UDI
- Description
- A component of an x-ray system used in diagnostic x-ray imaging applications, e.g., planar x-ray imaging or mammography. 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
- 08809413810464 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
Radiographic Grid by Jpi Healthcare, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Stationary x-ray grid.
- MS X-RAY GRID — Mitaya Manufacturing Co., Ltd. · Class I
- MS X-RAY GRID — Mitaya Manufacturing Co., Ltd. · Class I
- MS X-RAY GRID — Mitaya Manufacturing Co., Ltd. · Class I
- MS X-RAY GRID — Mitaya Manufacturing Co., Ltd. · Class I
- MS X-RAY GRID — Mitaya Manufacturing Co., Ltd. · Class I
- MS X-RAY GRID — Mitaya Manufacturing Co., Ltd. · Class I
- MS X-RAY GRID — Mitaya Manufacturing Co., Ltd. · Class I
- MS X-RAY GRID — Mitaya Manufacturing Co., Ltd. · Class I
Cleared under the same submission
K945327 also covers:
- Box for radiographic Grid-1000((G-1(outside 620mmx180mmx610mm)) — Jpi Healthcare, Inc.
- Box for radiographic Grid-1000(11"x13"(outside 395mmx380mm)) — Jpi Healthcare, Inc.
- Box for radiographic Grid-1000(15"x15"(outside 446mmx481mm)) — Jpi Healthcare, Inc.
- Box for radiographic Grid-1000(15"x18"(outside 523mmx481mm) — Jpi Healthcare, Inc.
- Box for radiographic Grid-1000(18"x18"(outside 525mmx560mm)) — Jpi Healthcare, Inc.
- Box for radiographic Grid-1000(9"x11"(outside 345mmx329mm)) — Jpi Healthcare, Inc.
- Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm)) — Jpi Healthcare, Inc.
- Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm), packing quantity:1) — Jpi Healthcare, Inc.
- Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm), packing quantity:2) — Jpi Healthcare, Inc.
- Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm), packing quantity:3) — Jpi Healthcare, Inc.
- Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm), packing quantity:4) — Jpi Healthcare, Inc.
- Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm), packing quantity:5) — Jpi Healthcare, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Jpi Healthcare, Inc.
Sources (1)
- FDA UDI f11c58ef-9a82-4e1b-8e60-bc4191bc6d63 35 fields · synced Jun 8, 2026