FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
K Number: K241850
·
Decision Aug 26, 2024
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
21
Applicant Total
24
Review Days
60
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Basic Information
- Device Name
- ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
- K Number
- K241850
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1650
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ulrich GmbH & Co. KG
- Date Received
- June 27, 2024
- Decision Date
- August 26, 2024
- Product Code
- IZQ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IZQ | Injector, Contrast Medium, Automatic | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IZQ), ordered by most recent decision date.
ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
FDA 510(k)
FDA Class 2
·Cardiovascular
ulrichINJECT CT Motion (XD 8000)
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FDA Class 2
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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)
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)
FDA 510(k)
FDA Class 2
·Cardiovascular
ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
FDA 510(k)
FDA Class 2
·Cardiovascular
ulrichINJECT CT motion
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Ulrich GmbH & Co. KG
| K Number | Device Name | ||
|---|---|---|---|
| K252281 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | Nov 18, 2025 | Substantially Equivalent |
| K251295 | ulrichINJECT CT Motion (XD 8000) | Nov 7, 2025 | Substantially Equivalent |
| K233737 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | Apr 19, 2024 | Substantially Equivalent |
| K210541 | ulrichINJECT CT motion | Aug 6, 2021 | Substantially Equivalent |
| K202227 | Artus cervical plate system | Sep 14, 2020 | Substantially Equivalent |
| K192872 | ulrichINJECT CT Motion | Jul 2, 2020 | Substantially Equivalent |
| K192117 | Small VBR | Nov 1, 2019 | Substantially Equivalent |
| K171392 | ulrichINJECT CT motion | Nov 9, 2017 | Substantially Equivalent |
| K161032 | neon3 universal OCT spinal stabilization | Dec 22, 2016 | Substantially Equivalent |
| K161723 | ulrich Transfer Set | Dec 21, 2016 | Substantially Equivalent |