Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- MiscellaneousMiscellaneous
- 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
- 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)
- K152361OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System2Cleared 510(K)
- K091734SONIC SHOT GX2Cleared 510(K)
- K063503OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION2Cleared 510(K)
- K062449EMPOWERMR INJECTOR SYSTEM, MODEL 97302Cleared 510(K)
- K063090MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY2Cleared 510(K)
- K062265CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM2Cleared 510(K)
- K031571EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 98252Cleared 510(K)
- K983314PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM2Cleared 510(K)
- K984058ACIST INJECTOR SYSTEM, MODEL CL100 H2Cleared 510(K)
- K951005KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2)2Cleared 510(K)
- K760641MYELOGRAPHY TRAY W/CHYNN MYELOGRAPHY N2Cleared 510(K)
- K760643MYELOGRAPHY TRAY W/CUATICO MYELOGRAP N2Cleared 510(K)
- 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
- HematologyReview Panel
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- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
ACIST INJECTOR SYSTEM, MODEL CL100 H
- Page Type
- Cleared 510(K)
- 510(k) Number
- K984058
- 510(k) Type
- Traditional
- Applicant
- ACIST MEDICAL SYSTEMS
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/11/1999
- Days to Decision
- 90 days
- Submission Type
- Summary