R650 Qdasm Collimator
FDA 510(k) K093572 · Omega Medical Imaging, Inc.
510(k) numberK093572
Submission
- Device name
- R650 Qdasm Collimator
- Applicant
- Omega Medical Imaging, Inc.
Sanford, FL, US - Received
- November 18, 2009
- Decision date
- February 3, 2010
- 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 |
| 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 |
| 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 |
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Questions and answers
When was R650 Qdasm Collimator cleared by the FDA?
R650 Qdasm Collimator (K093572) received a 510(k) decision of Substantially Equivalent on February 3, 2010, 77 days after the submission was received.
What is the product code of K093572?
The FDA product code is IZW – Collimator, Automatic, Radiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1610.