R 302
FDA 510(k) K946320 · Ralco S.R.L.
510(k) numberK946320
Submission
- Device name
- R 302
- Applicant
- Ralco S.R.L.
Italy, IT - Received
- December 28, 1994
- Decision date
- May 11, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code KPW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K093596 | Lumos, Model R 72BKPW · Traditional | Lumos, Inc. | 01/12/2010SE |
| K062788 | Collimator, Model M-38KPW · Traditional | Umi International | 12/28/2006SE |
| K030487 | R 72KPW · Traditional | Ralco S.R.L. | 08/01/2003SE |
| K954310 | BLA-800AKPW · Traditional | Toshiba Medical Systems | 10/18/1995SE |
| K914184 | P2020-8-0 Beam-Limiting DeviceKPW · Traditional | Precise Optics | 11/27/1991SE |
| K904587 | Densicomp 250KPW · Traditional | L. Keroack Co. | 01/24/1991SE |
| K904044 | TF-63SAKPW · Traditional | Toshiba America Medical Systems, In.C | 11/29/1990SE |
| K904489 | Eureka Extension CylindersKPW · Traditional | Eureka X-Ray Tube Corp. | 10/15/1990SE |
| K820306 | Ralco Collimator, Automatic RadiographicKPW · Traditional | Tecnomed, Inc. | 03/05/1982SE |
| K820305 | Ralco Collimators, Manual RadiographicKPW · Traditional | Tecnomed, Inc. | 03/04/1982SE |
More from Tecnomed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K110856 | RalcoIZX · Traditional | 08/10/2011SE |
| K091517 | Ralco, Model R225 AcsIZW · Traditional | 07/14/2009SE |
| K083029 | Model R605DASM Automatic X-Ray CollimatorIZW · Traditional | 12/05/2008SE |
| K072780 | Model R302DACS/A Automatic X-Ray CollimatorIZW · Traditional | 11/26/2007SE |
| K030487 | R 72KPW · Traditional | 08/01/2003SE |
Questions and answers
When was R 302 cleared by the FDA?
R 302 (K946320) received a 510(k) decision of Substantially Equivalent on May 11, 1995, 134 days after the submission was received.
What is the product code of K946320?
The FDA product code is KPW – Device, Beam Limiting, X-Ray, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1610.