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Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
DQF
Actuator, Syringe, Injector Type
2
Product Code
DQI
Withdrawal/Infusion Pump
2
Product Code
DXT
Injector And Syringe, Angiographic
2
Product Code
IZQ
Injector, Contrast Medium, Automatic
2
Product Code
K
24
1849
MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)
2
Cleared 510(K)
K
24
1850
ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
2
Cleared 510(K)
K
23
3737
ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
2
Cleared 510(K)
K
21
0541
ulrichINJECT CT motion
2
Cleared 510(K)
K
19
2872
ulrichINJECT CT Motion
2
Cleared 510(K)
K
17
1392
ulrichINJECT CT motion
2
Cleared 510(K)
K
15
1048
CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set
2
Cleared 510(K)
K
15
2361
OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System
2
Cleared 510(K)
K
09
1734
SONIC SHOT GX
2
Cleared 510(K)
K
06
3503
OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION
2
Cleared 510(K)
Show All 19 Submissions
NKP
Injector, Contrast Medium, Automatic, Reprocessed
2
Product Code
NKT
Injector And Syringe, Angiographic, Reprocessed
2
Product Code
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
Subpart D—Pathology Instrumentation and Accessories
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 9 May 2025 at 11:05 pm
HO
/
subpart-b—cardiovascular-diagnostic-devices
/
IZQ
/
K171392
View Source
ulrichINJECT CT motion
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K171392
510(k) Type
Traditional
Applicant
ulrich GmbH & Co. KG
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
11/9/2017
Days to Decision
182 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
DQF
Actuator, Syringe, Injector Type
DQI
Withdrawal/Infusion Pump
DXT
Injector And Syringe, Angiographic
IZQ
Injector, Contrast Medium, Automatic
K
24
1849
MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)
K
24
1850
ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
K
23
3737
ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
K
21
0541
ulrichINJECT CT motion
K
19
2872
ulrichINJECT CT Motion
K
17
1392
ulrichINJECT CT motion
K
15
1048
CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set
K
15
2361
OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System
K
09
1734
SONIC SHOT GX
K
06
3503
OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION
Show All 19 Submissions
NKP
Injector, Contrast Medium, Automatic, Reprocessed
NKT
Injector And Syringe, Angiographic, Reprocessed
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—General Hospital and Personal Use Monitoring Devices
Subpart D—Pathology Instrumentation and Accessories
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
Subpart G—Miscellaneous Devices
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
HO
/
subpart-b—cardiovascular-diagnostic-devices
/
IZQ
/
K171392
View Source
ulrichINJECT CT motion
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K171392
510(k) Type
Traditional
Applicant
ulrich GmbH & Co. KG
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
11/9/2017
Days to Decision
182 days
Submission Type
Summary