R605 Facs Collimeter
FDA 510(k) K050092 · Omega Medical Imaging, Inc.
510(k) numberK050092
Submission
- Device name
- R605 Facs Collimeter
- Applicant
- Omega Medical Imaging, Inc.
Sanford, FL, US - Received
- January 14, 2005
- Decision date
- January 31, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| 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 |
| K091517 | Ralco, Model R225 AcsIZW · Traditional | Ralco S.R.L. | 07/14/2009SE |
| 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 |
| 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 |
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| K121293 | Cs-Series-Fp with 3030+OPTIONJAA · Traditional | 07/26/2012SE |
| K100102 | Cs-Series-FpOWB · Traditional | 08/31/2010SE |
| K093572 | R650 Qdasm CollimatorIZW · Traditional | 02/03/2010SE |
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Questions and answers
When was R605 Facs Collimeter cleared by the FDA?
R605 Facs Collimeter (K050092) received a 510(k) decision of Substantially Equivalent on January 31, 2005, 17 days after the submission was received.
What is the product code of K050092?
The FDA product code is IZW – Collimator, Automatic, Radiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1610.