IXJ · Grid, Radiographic
Radiology · 21 CFR 892.1910 · Class 1
Overview
| Product Code | IXJ |
|---|---|
| Device Name | Grid, Radiographic |
| Regulation | 21 CFR 892.1910 |
| Device Class | Class 1 |
| Review Panel | Radiology |
Identification
A radiographic grid is a device that consists of alternating radiolucent and radiopaque strips intended to be placed between the patient and the image receptor to reduce the amount of scattered radiation reaching the image receptor.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
Recent Cleared Devices (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K964025 | MITAYA ALUMINUM INTERSPACED X-RAY GRID | X-Ray Accessory Corp. | Jun 13, 1997 | SESE |
| K963893 | FIBRE INTERSPACED X-RAY GRID | Smit Rontgen | Nov 7, 1996 | SESE |
| K962338 | RADIOGRAPHIC GRID | Unidex Group, Inc. | Jul 3, 1996 | SESE |
| K954294 | HIGH TRANSMISSION CELLULAR (HTC) GRIDS 18X24 CM & 24X30 CM SIZES | Thermotrex Corp. | Feb 2, 1996 | SESE |
| K945697 | SK S-RAY GRIDS | Seibu Techno Coproration | Jan 31, 1995 | SESE |
| K945327 | JPI X-RAY GRID | Jpi America, Inc. | Jan 20, 1995 | SESE |
| K941626 | GRIDGIL | Gilardoni S.P.A. | May 13, 1994 | SESE |
| K940309 | X-RAY GRID (RADIOLOGICAL GRID) | J.P.I. Chicago Co. | Apr 22, 1994 | SESE |
| K926445 | SOYEE ALUMINUM INTERSPACED X-RAY GRID | X-Ray Accessories Mfg. Co. | Apr 7, 1993 | SESE |
| K926261 | JPI ALUMINUM INTERSPACED X-RAY GRID | Jpi, Inc. | Mar 18, 1993 | SESE |
| K925997 | KODAK EKTASCAN SP CASSETTE | Eastman Kodak Company | Dec 17, 1992 | SESE |
| K901012 | RADIOGRAPHIC GRID | Infab Corp. | Mar 28, 1990 | SESE |
| K883527 | GRID/RADIOGRAPHIC | Umi, Inc. | Sep 2, 1988 | SESE |
| K854459 | TBX MEDICAL X-RAY TABLE | Gendex Corp. | Feb 12, 1986 | SESE |
| K837776 | AOR X-RAY ALIGMENT PAD | Zimmer, Inc. | Aug 18, 1983 | SESE |
Top Applicants
- Zimmer, Inc. — 1 clearance
- X-Ray Accessory Corp. — 1 clearance
- X-Ray Accessories Mfg. Co. — 1 clearance
- Unidex Group, Inc. — 1 clearance
- Umi, Inc. — 1 clearance
