Automatic contrast media injectors for CT, MRI and angiography · flow rate, volume per injection, pressure limit, phases, contrast and saline delivery, syringe-based and syringeless designs, scanner interface, and US FDA product code IZQ (21 CFR 870.1650)
A contrast media injector is a powered pump that pushes contrast agent and saline into a patient's vein at a set flow rate and volume, timed with the imaging scan. Ask three things first: which imaging modality (CT, MRI or angiography) it serves, which flow rate, volume, pressure limit and phase programme you need, and how it connects to the scanner and to your consumables.
Automatic contrast media injection systems for CT, MRI and angiography, with their syringes or tubing sets. Manual syringes, contrast agents and ultrasound enhancing-agent pumps are outside this page except where compared.
01
Bayer's MEDRAD Centargo CT Injection System is described in its FDA 510(k) summary as an automated system for controlled, automatic venous administration of contrast agent and 0.9% saline to patients undergoing CT. It lists contrast and saline injection rates of 0.1–10 mL/s. It delivers 1–200 mL per contrast or flush phase and up to 400 mL in simultaneous DualFlow phases, in 1 mL steps, with a user-programmable pressure limit of 20.68 bar (300 psi). Volume accuracy is ±(2% + 1) mL for a single contrast or saline phase. The system supports up to 60 phases per patient (6 phases per injection, up to 10 injections). [1]
The ulrichINJECT CT motion 510(k) summary lists the same 0.1–10 mL/s rate range and 1–200 mL of contrast per patient, with up to 400 mL total of contrast and saline. Its pressure limit is 195 psi, user-programmable or automatic, and its volume accuracy is ±5% for 10–200 mL of contrast. Its SYNCopen interface starts the injector and CT scanner together and passes information to the scanner. [2]
Editorial calculation: 300 psi ≈ 2.07 MPa and 195 psi ≈ 1.34 MPa; at 10 mL/s, a 100 mL contrast phase takes 10 s.
Give the supplier the modality, the scanner model and interface, the flow-rate and volume range, the pressure limit, the number of phases and protocols, dual-flow needs, the syringe or syringeless consumable system and its cost per patient, the mounting (pedestal or ceiling), the regulatory approvals required in your market, and the service and training expected.
02
FDA classifies automatic contrast medium injectors under product code IZQ, Class II, regulation 21 CFR 870.1650. The 510(k) database lists clearances under this code from makers including Ulrich, Imaxeon (MEDRAD Centargo), Bracco, Liebel-Flarsheim, Nemoto Kyorindo and E-Z-Em. [3]
Designs differ in how contrast is held. Ulrich describes ulrichINJECT CT motion as a syringeless contrast media management system made up of a terminal, an injector and a tubing system, in which only the tubing contacts the patient. [2]
LnkMed, a Chinese maker, lists CT, DSA (angiography) and MRI contrast media injectors along with high-pressure syringes for each. [4]
03
The FDA 510(k) summary K252281 (2025) for the ulricheasyINJECT Max 2M and Max 3 describes a syringeless contrast media management system indicated for venous administration of contrast and saline in MR procedures, for gadobutrol, gadopiclenol, gadobenate dimeglumine and gadoterate meglumine, and states that it is not intended for high-pressure angiography. [5]
The summary states that only the tubing system contacts the patient, with indirect contact with the blood path for a few minutes, that check valves prevent backflow of media, and that the disposables are sterilised by ethylene oxide. Single-dose containers expire four hours after opening and bulk packages and saline after 24 hours unless the media labeling states otherwise. [5]
Editorial calculation: 159.5 psi ≈ 1.10 MPa and 203 psi ≈ 1.40 MPa, against 300 psi (≈ 2.07 MPa) for the CT injector above; a cassette limit of 96 bottles in 24 hours averages 4 bottles per hour, so plan cassette changes around your MR list length. [5] [1]
| MR injector value (K252281) | Value |
|---|---|
| Injection rate, contrast and saline | 0.1–10.0 mL/s |
| Volume | 1–200 mL contrast per patient; 400 mL total contrast and saline |
| Accuracy | Volume ±5% for 10–400 mL; flow rate ±5% |
| Pressure limit | 159.5 psi, user-programmable or automatic |
| Phases | 40 per protocol; pause 0–1,800 s in 1 s steps |
| Air detection | Optical refraction sensor; 0.05 mL detection limit, 1 mL alarm limit |
| Occlusion detection | Piezo-resistive pressure sensor; alarm at 203 psi |
| Needle size | 16–24 G |
| Consumable time limits | Cassette 24 h or 96 bottles; patient tubing per patient, 12 h limit; spike single-bottle |
State the modality and contrast agents, consumable life limits per day and per patient, air and occlusion detection limits, and whether angiographic pressures are needed.
04
A contrast injector quotation needs values for your imaging work. The table explains each field, gives published values where a reviewed source states them, and says what to ask the supplier for.
| Field | What it means and published values | Ask the supplier for |
|---|---|---|
| Flow rate | Example: 0.1–10 mL/s. [1] [2] | Range for your protocols. |
| Volume | Examples: 1–200 mL per phase; up to 400 mL total. [1] [2] | Reservoir and phase volumes. |
| Pressure limit | Examples: 300 psi; 195 psi (CT) [1] [2]; 159.5 psi (MR). [5] | Limit and setting. |
| Accuracy | Examples: ±(2% + 1) mL; ±5% [1] [2]; flow ±5%. [5] | Test method. |
| Phases | Example: up to 60 per patient. [1] | Protocol memory. |
| Regulation | FDA IZQ, Class II, 21 CFR 870.1650. [3] | Clearance number; CE. |
| Air and occlusion detection | 0.05 mL air detection limit; occlusion alarm 203 psi in one MR system. [5] | Detection principles and limits. |
| Consumable life | Cassette 24 h or 96 bottles; tubing per patient. [5] | Limits per day and patient. |
05
Paste it into your enquiry below or into an email to a maker, then replace every bracket.
Modality: [CT; MRI; DSA] Scanner: [make; model; interface] Protocols: [flow rate; volume; phases; dual flow] Pressure: [limit] Consumables: [syringes; syringeless sets; cost per patient] Mounting: [pedestal; ceiling] Regulatory: [FDA 510(k); CE; local registration]
These companies list contrast media injectors.
Lists CT, DSA and MRI contrast media injectors and high-pressure syringes.
Product scope checked 2026-10-11
Explore company information and manufacturing capabilities, then discuss the scope of your project with a relevant supplier.
Current FDA-cleared CT systems list 0.1–10 mL/s for contrast and saline. [1] [2]
Published examples are 300 psi (MEDRAD Centargo) and 195 psi (ulrichINJECT CT motion). [1] [2]
Under FDA product code IZQ, Class II, 21 CFR 870.1650, through 510(k) clearance. [3]
Not necessarily; one FDA-cleared MR system states it is not intended for high-pressure angiography and lists a 159.5 psi pressure limit. [5]
One MR system lists an optical sensor with a 0.05 mL detection limit and a 1 mL alarm limit. [5]
Sources checked 2026-10-12. The 510(k) summaries are regulatory filings held by the US FDA; openFDA records list clearances. LnkMed describes its own range.
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