Ralco, Model R225 Acs
FDA 510(k) K091517 · Ralco S.R.L.
510(k) numberK091517
Submission
- Device name
- Ralco, Model R225 Acs
- Applicant
- Ralco S.R.L.
Deerfield, IL, US - Received
- May 22, 2009
- Decision date
- July 14, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code IZW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K101039 | Shimadzu Collimator R-300IZW · Abbreviated | Shimadzu Corp. | 09/20/2010SE |
| K093572 | R650 Qdasm CollimatorIZW · Traditional | Omega Medical Imaging, Inc. | 02/03/2010SE |
| K090578 | Shimadzu Collimator R-30HIZW · Abbreviated | Shimadzu Corp. | 11/06/2009SE |
| K083029 | Model R605DASM Automatic X-Ray CollimatorIZW · Traditional | Ralco S.R.L. | 12/05/2008SE |
| K072780 | Model R302DACS/A Automatic X-Ray CollimatorIZW · Traditional | Ralco S.R.L. | 11/26/2007SE |
| K073124 | Collimare Collimator FamilyIZW · Abbreviated | Collimare, LLC | 11/16/2007SE |
| K050092 | R605 Facs CollimeterIZW · Traditional | Omega Medical Imaging, Inc. | 01/31/2005SE |
| K031597 | Dunlee Format Collimator FamilyIZW · Traditional | Philips Medical Systems North America Co. | 07/21/2003SE |
| K990423 | Philips Nicol Collimator FamilyIZW · Traditional | Philips Medical Systems, Inc. | 03/15/1999SE |
| K984414 | Xre Collimator with Spectral FilterIZW · Traditional | Trex Medical Corp. | 12/30/1998SE |
More from Trex Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K110856 | RalcoIZX · Traditional | 08/10/2011SE |
| 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 |
| K946320 | R 302KPW · Traditional | 05/11/1995SE |
Questions and answers
When was Ralco, Model R225 Acs cleared by the FDA?
Ralco, Model R225 Acs (K091517) received a 510(k) decision of Substantially Equivalent on July 14, 2009, 53 days after the submission was received.
What is the product code of K091517?
The FDA product code is IZW – Collimator, Automatic, Radiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1610.