Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)
FDA 510(k) K161724 · Radiomed Corporation
510(k) numberK161724
Submission
- Device name
- Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)
- Applicant
- Radiomed Corporation
Bartlett, TN, US - Received
- June 22, 2016
- Decision date
- April 28, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K120859 | Pre-Loaded Gold Visicoil CK MarkerKXK · Special | 04/19/2012SE |
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| K031206 | Radiomed Soft Tissue MarkerJAK · Special | 05/21/2003SE |
| K022326 | Radiomed MarkerJAK · Traditional | 01/31/2003SE |
| K013660 | GenetraKXK · Special | 12/05/2001SE |
| K001070 | Radiomed SourceKXK · Traditional | 10/24/2000SE |
Questions and answers
When was Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) cleared by the FDA?
Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) (K161724) received a 510(k) decision of Substantially Equivalent on April 28, 2017, 310 days after the submission was received.
What is the product code of K161724?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.