510(k) K963893
- Device
- FIBRE INTERSPACED X-RAY GRID
- Applicant
- SMIT RONTGEN
- 510(k) number
- K963893
- Product code
- IXJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-11-07
- Date received
- 1996-09-27
- Regulation
- 892.1910
- Classification name
- Grid, Radiographic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ING. R.W. RIJNTJES
- Address
- Postbox 218 Md Eindhoven NL 5600 5600
FDA Registration Numbers#
- 3008141750
- 2431224
- 8030318
- 3006115340
- 9021987
- 3001556265
- 3003768277
- 9680825
- 3016674288
- 3009077524
- 1418964
- 3003768251
- 1225677
- 1317307
- 1450835
- 2529454
- 3002532594
- 3002808157
- 3000126629
- 3002707445
Source Documents#
Other 510(k) Records For Product Code IXJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K964025 | MITAYA ALUMINUM INTERSPACED X-RAY GRID | X-Ray Accessory Corp. | 1997-06-13 |
| K962338 | RADIOGRAPHIC GRID | Unidex Group, Inc. | 1996-07-03 |
| K954294 | HIGH TRANSMISSION CELLULAR (HTC) GRIDS 18X24 CM & 24X30 CM SIZES | Thermotrex Corp. | 1996-02-02 |
| K945697 | SK S-RAY GRIDS | Seibu Techno Coproration | 1995-01-31 |
| K945327 | JPI X-RAY GRID | Jpi America, Inc. | 1995-01-20 |
| K941626 | GRIDGIL | Gilardoni S.P.A. | 1994-05-13 |
| K940309 | X-RAY GRID (RADIOLOGICAL GRID) | J.P.I. Chicago Co. | 1994-04-22 |
| K926445 | SOYEE ALUMINUM INTERSPACED X-RAY GRID | X-Ray Accessories Mfg. Co. | 1993-04-07 |
| K926261 | JPI ALUMINUM INTERSPACED X-RAY GRID | Jpi, Inc. | 1993-03-18 |
| K925997 | KODAK EKTASCAN SP CASSETTE | Eastman Kodak Company | 1992-12-17 |
| K901012 | RADIOGRAPHIC GRID | Infab Corp. | 1990-03-28 |
| K883527 | GRID/RADIOGRAPHIC | Umi, Inc. | 1988-09-02 |
| K854459 | TBX MEDICAL X-RAY TABLE | Gendex Corp. | 1986-02-12 |
| K837776 | AOR X-RAY ALIGMENT PAD | Zimmer, Inc. | 1983-08-18 |
Legacy Summary#
summary
FDA Review#
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