Medrad Stellant CT Injector System with XDS Accessory
FDA 510(k) K063090 · Medrad, Inc.
510(k) numberK063090
Submission
- Device name
- Medrad Stellant CT Injector System with XDS Accessory
- Applicant
- Medrad, Inc.
Indianola, PA, US - Received
- October 10, 2006
- Decision date
- March 27, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IZQ – Injector, Contrast Medium, Automatic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1650
- Specialty
- Cardiovascular
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| K241849 | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient…IZQ · Traditional | Imaxeon Pty, Ltd. | 11/05/2024SE |
| K241850 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT…IZQ · Traditional | Ulrich GmbH & Co. KG | 08/26/2024SE |
| K233737 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT…IZQ · Traditional | Ulrich GmbH & Co. KG | 04/19/2024SE |
| K210541 | ulrichINJECT CT motionIZQ · Traditional | Ulrich GmbH & Co. KG | 08/06/2021SE |
| K192872 | ulrichINJECT CT MotionIZQ · Traditional | Ulrich GmbH & Co. KG | 07/02/2020SE |
| K171392 | ulrichINJECT CT motionIZQ · Traditional | Ulrich GmbH & Co. KG | 11/09/2017SE |
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Questions and answers
When was Medrad Stellant CT Injector System with XDS Accessory cleared by the FDA?
Medrad Stellant CT Injector System with XDS Accessory (K063090) received a 510(k) decision of Substantially Equivalent on March 27, 2007, 168 days after the submission was received.
What is the product code of K063090?
The FDA product code is IZQ – Injector, Contrast Medium, Automatic, a Class II (moderate risk) device regulated under 21 CFR 870.1650.