Anesthesiology
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- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- DQFActuator, Syringe, Injector Type2Product Code
- DQIWithdrawal/Infusion Pump2Product Code
- DXTInjector And Syringe, Angiographic2Product Code
- IZQInjector, Contrast Medium, Automatic2Product Code
- K252281ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)2Cleared 510(K)
- K251295ulrichINJECT CT Motion (XD 8000)2Cleared 510(K)
- K252689MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)2Cleared 510(K)
- K241849MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)2Cleared 510(K)
- K241850ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)2Cleared 510(K)
- K233737ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)2Cleared 510(K)
- K210541ulrichINJECT CT motion2Cleared 510(K)
- K192872ulrichINJECT CT Motion2Cleared 510(K)
- K171392ulrichINJECT CT motion2Cleared 510(K)
- K151048CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set2Cleared 510(K)
Show All 22 Submissions
- NKPInjector, Contrast Medium, Automatic, Reprocessed2Product Code
- NKTInjector And Syringe, Angiographic, Reprocessed2Product Code
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
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MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K252689
- 510(k) Type
- Special
- Applicant
- Imaxeon Pty, Ltd.
- Country
- Australia
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/24/2025
- Days to Decision
- 29 days
- Submission Type
- Summary