Dunlee Format Collimator Family
FDA 510(k) K031597 · Philips Medical Systems North America Co.
510(k) numberK031597
Submission
- Device name
- Dunlee Format Collimator Family
- Applicant
- Philips Medical Systems North America Co.
Bothell, WA, US - Received
- May 21, 2003
- Decision date
- July 21, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
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| 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 Dunlee Format Collimator Family cleared by the FDA?
Dunlee Format Collimator Family (K031597) received a 510(k) decision of Substantially Equivalent on July 21, 2003, 61 days after the submission was received.
What is the product code of K031597?
The FDA product code is IZW – Collimator, Automatic, Radiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1610.