SK S-Ray Grids
FDA 510(k) K945697 · Seibu Techno Coproration
510(k) numberK945697
Submission
- Device name
- SK S-Ray Grids
- Applicant
- Seibu Techno Coproration
Japan, JP - Received
- November 17, 1994
- Decision date
- January 31, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code IXJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K964025 | Mitaya Aluminum Interspaced X-Ray GridIXJ · Traditional | X-Ray Accessory Corp. | 06/13/1997SE |
| K963893 | Fibre Interspaced X-Ray GridIXJ · Traditional | Smit Rontgen | 11/07/1996SE |
| K962338 | Radiographic GridIXJ · Traditional | Unidex Group, Inc. | 07/03/1996SE |
| K954294 | High Transmission Cellular (HTC) Grids 18X24 CM & 24X30 CM SizesIXJ · Traditional | Thermotrex Corp. | 02/02/1996SE |
| K945327 | Jpi X-Ray GridIXJ · Traditional | Jpi America, Inc. | 01/20/1995SE |
| K941626 | GridgilIXJ · Traditional | Gilardoni S.P.A. | 05/13/1994SE |
| K940309 | X-Ray Grid (Radiological Grid)IXJ · Traditional | J.P.I. Chicago Co. | 04/22/1994SE |
| K926445 | Soyee Aluminum Interspaced X-Ray GridIXJ · Traditional | X-Ray Accessories Mfg. Co. | 04/07/1993SE |
| K926261 | Jpi Aluminum Interspaced X-Ray GridIXJ · Traditional | Jpi, Inc. | 03/18/1993SE |
| K925997 | Kodak Ektascan SP CassetteIXJ · Traditional | Eastman Kodak Company | 12/17/1992SE |
Questions and answers
When was SK S-Ray Grids cleared by the FDA?
SK S-Ray Grids (K945697) received a 510(k) decision of Substantially Equivalent on January 31, 1995, 75 days after the submission was received.
What is the product code of K945697?
The FDA product code is IXJ – Grid, Radiographic, a Class I (low risk) device regulated under 21 CFR 892.1910.