ulrichINJECT CT motion
Device Facts
| Record ID | K171392 |
|---|---|
| Device Name | ulrichINJECT CT motion |
| Applicant | Ulrich GmbH & Co. KG |
| Product Code | IZQ · Cardiovascular |
| Decision Date | Nov 9, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1650 |
| Device Class | Class 2 |
Indications for Use
ulrichINJECT CT motion is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in computed tomography (CT) applications. ulrichINJECT CT motion is specifically indicated for use in CT procedures for the delivery of Omnipaque™ (lohexol) Injection, solution - GE Healthcare Inc. contrast media as supplied in Imaging Bulk Packages (IBP). Pump tubing-flex is used for a maximum time of twenty four (24) hours. When used with Omnipaque™ IBP, a maximum of 19 bottles of contrast media can be used or maximum time of twenty four (24) hours of Pump tubing-flex, or whichever comes first, with a maximum of eight (8) hours per contrast media or saline container. Spike for CT disposable is for single-bottle use only and must be discarded with the media container. The Patient tubing must be discarded after each patient procedure. ulrichINIECT CT motion is to be used only by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of contrast agent.
Device Story
Syringeless contrast media management system; utilizes peristaltic pump to deliver contrast media and saline from bulk containers to patient. System components: injector head, terminal, and disposable tubing set (spike, pump tubing-flex, patient tubing). Used in CT suites by trained healthcare professionals. Device features air detectors (ultrasound), pressure controls, and check valves to ensure safety. Software controls prevent disposable reuse and manage injection protocols (up to 40 phases). Output: automated fluid delivery for diagnostic imaging. Benefits: precise, controlled contrast administration; reduced waste via bulk packaging; enhanced imaging quality through flexible protocol programming.
Clinical Evidence
No clinical studies performed. Bench testing included electromagnetic compatibility (IEC 60601-1, 60601-1-2), sterilization validation (ISO 11135-1), shelf-life/packaging (ISO 11607-1), biocompatibility (ISO 10993-1), and performance testing (ISO 8536-4). Contamination control studies (process simulation, microbial ingress, cross-contamination) confirmed sterility maintenance. Human factors/usability assessments conducted in simulated environments.
Technological Characteristics
Syringeless peristaltic pump system. Materials: PVC/PUR tubing. Energy: 110-240V AC or rechargeable battery. Connectivity: Standalone terminal. Sterilization: Ethylene Oxide (EtO). Software: Multi-layered software controls for pressure, air detection, and disposable usage tracking. Form factors: Mobile pedestal, ceiling, or wall-mounted.
Indications for Use
Indicated for controlled, automatic venous administration of contrast media and saline in CT diagnostic exams. Specifically for delivery of Omnipaque (Iohexol) IBP. Contraindicated for use outside of licensed healthcare facilities or without supervision of trained healthcare professionals.
Regulatory Classification
Special Controls
*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Predicate Devices
- CT Exprès 3D Contrast Media Delivery System (K151048)
Submission Summary (Full Text)
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November 9, 2017
ulrich GmbH & Co. KG % Rita King CEO MethodSense, Inc. PO Box 110352 Durham, North Carolina 27709
Re: K171392
Trade/Device Name: ulrichINJECT CT motion Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector And Syringe Regulatory Class: Class II Product Code: IZO Dated: October 3, 2017 Received: October 10, 2017
Dear Rita King:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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## Page 2 - Rita King
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K171392
Device Name ulrichINJECT CT motion
#### Indications for Use (Describe)
ulrichINJECT CT motion is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in computed tomography (CT) applications.
ulrichINJECT CT motion is specifically indicated for use in CT procedures for the delivery of Omnipaque™ (lohexol) Injection, solution - GE Healthcare Inc. contrast media as supplied in Imaging Bulk Packages (IBP).
Pump tubing-flex is used for a maximum time of twenty four (24) hours. When used with Omnipaque™ IBP, a maximum of 19 bottles of contrast media can be used or maximum time of twenty four (24) hours of Pump tubing-flex, or whichever comes first, with a maximum of eight (8) hours per contrast media or saline container.
Spike for CT disposable is for single-bottle use only and must be discarded with the media container. The Patient tubing must be discarded after each patient procedure.
ulrichINIECT CT motion is to be used only by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of contrast agent.
Type of Use (Select one or both, as applicable)
| <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------------------|
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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## K171392
## 510(k) Summary
## ulrich GmbH & Co. KG
This 510(k) Summary is in conformance with 21 CFR 807.92
| Submitter: | ulrich GmbH & Co. KG<br>Buchbrunnenweg 12<br>89081 Ulm<br>Germany<br>Phone: +49 731 9654-1714<br>Fax: +49 731 9654-2807 |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Rita King, CEO<br>MethodSense, Inc.<br>Email: ritaking@methodsense.com<br>Phone: 919-313-3961<br>Fax: 919-313-3979 |
| Company Contact: | Sven Erdmann<br>Director Development & Product Management Devices |
| Date Prepared: | November 7, 2017 |
| Device Name and Classification | |
| Trade Name: | ulrichINJECT CT motion |
| Common Name: | Contrast Media Management System |
| Classification: | Class II |
| Regulation Number: | 21 CFR 870.1650, Angiographic Injector and Syringe |
| Classification Panel: | Cardiovascular Panel |
| Product Code: | IZQ |
| Predicate Device: | |
| Trade Name: | CT Exprès 3D Contrast Media Delivery System |
| Common Name: | Automatic injector for contrast media |
| 510(k) Submitter / Holder | Bracco Injeneering S.A. |
| 510(k) Number | K151048 |
| Classification: | Class II |
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## Device Description
ulrichINJECT CT motion is a syringeless contrast media management system that is designed for the controlled, automatic administration, on the venous side, of contrast media and saline, to human subjects undergoing diagnostic examinations in computed tomography (CT) applications.
The ulrichINJECT CT motion system consists of the CT motion terminal, CT motion injector and the CT motion tubing system.
ulrichINJECT CT motion uses a peristaltic pump as part of the injector which is designed to transport the media fluid through the CT motion tubing system (spikes for CT, CT motion pump tubing-flex and patient tubing for pump tubing-flex).
The only component of the ulrichINJECT CT motion that comes in contact with the patient is the ulrichINJECT CT motion tubing system. The tubing system consists of three components:
- . Spike for CT
- Pump tubing-flex .
- . Patient Tubing
The ulrichINJECT CT motion tubing system has indirect contact with the blood path of a patient for a limited duration (few minutes).
The ulrichINJECT CT motion system is also intended to be used with the following components, which are not supplied with the system:
- . Multiple patient use saline containers,
- . Omnipaque™ IBP contrast media containers, and
- . Cannula.
ulrichINJECT CT motion is specifically indicated for use in CT procedures for the delivery of Omnipaque™ (lohexol) Injection, solution - GE Healthcare Inc. contrast media as supplied in Imaging Bulk Packages (IBP).
ulrichINJECT CT motion is equipped with multiple hardware and software controls that work together for the intended use of the device. Controls include air detectors, which are designed to detect air without direct contact with the medium, pressure controls to manage and regulate pressure inside the tubing system, and check valves to prevent backflow of media and avoid retrograde contamination.
The ulrichINJECT CT motion is provided in three versions:
- Mobile pedestal version
- . Ceiling version
- Wall mounted version
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The mobile pedestal version consists of the injector head and the injector base and it is designed to operate with a rechargeable battery in addition to the power supply. The ceiling version and the wall mounted version consist of the injector head, a fixed height arm and a movable arm.
## Indications for Use
ulrichINJECT CT motion is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in computed tomography (CT) applications.
ulrichINJECT CT motion is specifically indicated for use in CT procedures for the delivery of Omnipaque™ (lohexol) Injection, solution - GE Healthcare Inc. contrast media as supplied in Imaging Bulk Packages (IBP).
Pump tubing-flex is used for a maximum time of twenty four (24) hours. When used with Omnipaque™ IBP, a maximum of 19 bottles of contrast media can be used or maximum time of twenty four (24) hours of Pump tubing-flex, or whichever comes first, with a maximum of eight (8) hours per contrast media or saline container.
Spike for CT disposable is for single-bottle use only and must be discarded with the media container. The Patient tubing must be discarded after each patient procedure.
ulrichINJECT CT motion is to be used only by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of contrast agent.
## Risk Analysis Method
The ulrichINJECT CT motion was assessed to determine the risks to health associated with the use of the device in the CT suite and evaluated risks related to safety, contamination and usability. A risk analysis was conducted in accordance with ISO 14971:2007, Medical devices --Application of risk management to medical devices. Several risks were assessed, including, but not limited to, device malfunction, adverse tissue reaction, infection and improper use.
### Substantial Equivalence
ulrichINJECT CT motion is substantially equivalent to CT Expres 3D Contrast Media Delivery System by Bracco Injeneering S.A., (K151048) currently on the market.
ulrichINJECT CT motion has the same indications for use as the Bracco Injeneering CT Expres 3D Contrast Media Delivery System and uses equivalent overall design and operating principals.
The table below provides a detailed comparison of ulrichINJECT CT motion to the predicate device.
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| Product Name: | ulrichINJECT CT motion<br>by ulrich Medical | CT Expres 3D Contrast<br>Media Delivery System by<br>Bracco Injeneering S.A.<br>K151048 | Comparison |
|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | ulrichINJECT CT motion is a contrast<br>media management system that is<br>indicated for the controlled,<br>automatic administration, on the<br>venous side, of contrast media and<br>saline (NaCl), to human subjects<br>undergoing diagnostic examinations<br>in computed tomography (CT)<br>applications. | The CT Expres 3D Contrast<br>Media Delivery System is<br>indicated for controlled<br>automatic administration, on<br>the venous side, of contrast<br>and saline, to human<br>subjects while undergoing<br>examination by means of a<br>computed tomography (CT)<br>scanner. | ulrichINJECT CT motion is<br>equivalent to CT Expres 3D.<br>The differences in the time limits<br>of the disposables components<br>are addressed through the<br>results of contamination control<br>studies. |
| | ulrichINJECT CT motion is<br>specifically indicated for use in CT<br>procedures for the delivery of<br>Omnipaque™ (lohexol) Injection,<br>solution - GE Healthcare Inc.<br>contrast media as supplied in<br>Imaging Bulk Packages (IBP). | The CT Expres 3D Contrast<br>Media Delivery System is<br>specifically indicated for use<br>in CT procedures for the<br>delivery of Isovue (lopamidol<br>Injection) contrast media as<br>supplied in Imaging Bulk<br>Package (IBP), for a<br>maximum of 20 bottles of | |
| | Pump tubing-flex is used for a<br>maximum time of twenty four (24)<br>hours. When used with<br>Omnipaque™ IBP, a maximum of 19<br>bottles of contrast media can be<br>used or maximum time of twenty four<br>(24) hours of Pump tubing-flex, or<br>whichever comes first, with a | contrast media or a<br>maximum of ten (10) hours,<br>whichever comes first, per<br>Day Set III HP disposable.<br>The Bottle Spike disposable<br>is for single-bottle use only<br>and must be discarded with<br>the contrast media bottle.<br>The Patient Set disposable<br>must be discarded after each | |
| Product Name: | ulrichINJECT CT motion<br>by ulrich Medical | CT Expres 3D Contrast<br>Media Delivery System by<br>Bracco Injeneering S.A.<br>K151048 | Comparison |
| | maximum of eight (8) hours per<br>contrast media or saline container.<br>Spike for CT disposable is for single-<br>bottle use only and must be<br>discarded with the media container.<br>The Patient tubing must be<br>discarded after each patient<br>procedure.<br>ulrichINJECT CT motion is to be<br>used only by and under quasi-<br>continuous supervision of trained<br>healthcare professionals in an<br>appropriate licensed healthcare<br>facility, in a room designated for<br>radiological procedures that involve<br>intravascular administration of<br>contrast agent. | patient procedure.<br>The CT Expres 3D is to be<br>used only by and under<br>quasi-continuous supervision<br>of trained health care<br>professionals in an<br>appropriate licensed health<br>care facility, in a room<br>designated for radiological<br>procedures that involve<br>intravascular administration<br>of a contrast agent. | |
| System Components | | | |
| System | Injector Head<br>Touch Terminal | CT Expres Injector Unit<br>CT Expres Control Panel | ulrichINJECT CT motion is<br>equivalent to CT Expres 3D. |
| Accessories | Injector Base<br>Wall Mount with moveable arm<br>Ceiling Mount with moveable arm<br>Contrast Media Housing with Heater | CT Expres Hand Switch<br>CT Expres Bottle Insulator<br>CT Expres Stand<br>CT Expres Ceiling mount | ulrichINJECT CT motion<br>Pedestal, Ceiling Mount and<br>Contrast Media Housing with<br>Heater are equivalent to the CT<br>Expres 3D Stand |
| Product Name: | ulrichINJECT CT motion<br>by ulrich Medical | CT Expres 3D Contrast<br>Media Delivery System by<br>Bracco Injeneering S.A.<br>K151048 | Comparison |
| | | | ulrichINJECT CT motion does<br>not include a hand switch. |
| Disposables | ulrichINJECT CT Motion Pump<br>Tubing-flex<br>Patient Tubing for Pump Tubing-flex<br>ulrichINJECT CT Motion Spike for<br>CT | CT Expres Day Set III HP<br>CT Expres Patient Set<br>CT Express Bottle Spike<br>Type B (25mm) | ulrichINJECT CT motion<br>disposables are equivalent to the<br>CT Expres 3D disposables. |
| Physical Design | | | |
| Weight | Injector: Approx. 79 kg<br>Terminal: Approx. 3 kg | Injector: Approx. 10 kg<br>Remote Control Panel:<br>Approx. 2.1 kg | ulrichINJECT CT motion weight<br>is equivalent to the CT Expres<br>3D weight.<br>ulrichINJECT CT motion Injector<br>is heavier than the CT Express<br>3D injector. However, this<br>difference does not have an<br>impact on the intended use of<br>the device. |
| Dimensions | Injector: 64.5 x 64.5 x 144.5 cm<br>Terminal: 31 x 27.5 x 17 cm | Injector: 44 x 32 x 16 cm<br>Remote Control Panel: 30 x<br>20 x 22 cm | ulrichINJECT CT motion<br>dimensions are equivalent to the<br>CT Expres 3D dimensions. |
| Power Requirement<br>Rated Voltage:<br>Rated Current:<br>Rated Frequency: | 110 to 240 V AC<br>1.6 A<br>50/60Hz | 110 to 240 V AC<br>1.6 A<br>50/60Hz | ulrichINJECT CT is identical to<br>the CT Expres 3D related to<br>power requirements. |
| Product Name: | ulrichINJECT CT motion<br>by ulrich Medical | CT Expres 3D Contrast<br>Media Delivery System by<br>Bracco Injeneering S.A.<br>K151048 | Comparison |
| Display Type | Color LCD Terminal with touch<br>screen | Color LCD with touch screen | ulrichINJECT CT motion<br>Terminal is equivalent to the CT<br>Expres 3D Console. |
| Characteristics | | | |
| Syringeless system | Yes | Yes | CT motion is identical to CT<br>Express 3D |
| Remote Operation | Yes, via the Touch Terminal | Yes, via the Remote Control<br>Panel and the Hand Switch | ulrichINJECT CT motion is<br>equivalent to the CT Expres 3D<br>related to remote operation. |
| Single Patient Use Disposable | Patient Tubing for Pump Tubing-flex | Patient Set | ulrichINJECT CT motion Patient<br>Tubing for Pump Tubing-flex is<br>equivalent to the CT Expres 3D<br>Patient Set.<br>CT Expres 3D Patient Set<br>includes the peristaltic pump into<br>the disposable. The peristaltic<br>pump is part of the injector of the<br>ulrichINJECT CT motion. This<br>difference in technology does not<br>affect the intended use of the<br>device. |
| Designed to Prevent Reuse of<br>Disposables | Yes - via the use of software<br>controls | Yes - via a breakaway pin<br>designed to break on<br>insertion | ulrichINJECT CT motion is<br>equivalent to the CT Expres 3D.<br>ulrichINJECT CT motion<br>provides software controls to |
| Product Name: | ulrichINJECT CT motion<br>by ulrich Medical | CT Expres 3D Contrast<br>Media Delivery System by<br>Bracco Injeneering S.A.<br>K151048 | Comparison |
| | | | prevent user from reuse of<br>disposables. |
| Rotary peristaltic pump | Yes | Yes | CT motion is equivalent to CT<br>Express 3D |
| Used to administer contrast<br>media and saline | Yes | Yes | CT motion is equivalent to CT<br>Express 3D |
| Disposable uses spikes to<br>spike media container | Yes | Yes | CT motion is equivalent to CT<br>Express 3D |
| Safety Stop Mechanism | Multi-layered software stops; Used<br>Patient Tubing detector and Pump<br>Tubing-flex detector | Multi-layered software stops;<br>Used Pump Tubing detector | CT motion is equivalent to CT<br>Express 3D |
| Volume Remaining Readout | Yes, displayed on control unit if<br>programmed volume is higher than<br>remaining volume | Yes, LED on injector head;<br>graphical and numeric on<br>LCD | CT motion is equivalent to CT<br>Express 3D |
| Programmable Pressure Limit | Yes, 195 PSI; user-programmable or<br>automatic | Yes, 8 bar (ca. 120 psi) | CT motion is equivalent to CT<br>Express 3D |
| Operational Characteristics | | | |
| Product Name: | ulrichINJECT CT motion<br>by ulrich Medical | CT Expres 3D Contrast<br>Media Delivery System by<br>Bracco Injeneering S.A.<br>K151048 | Comparison |
| Injection Capabilities | 40 phases per protocol | Up to 24 phases per patient<br>(8 phases per injection; up to<br>3 injections per patient) | ulrichINJECT CT motion is<br>equivalent to the CT Expres 3D.<br>ulrichINJECT CT motion<br>provides additional flexibility with<br>a greater number of phases for<br>programming different speed and<br>volume of contrast media and<br>saline for better imaging quality. |
| Injection Rates for Contrast<br>Media | 0.1 ml/s to 10.0 ml/s | 0.5-9.9 mL/s | ulrichINJECT CT motion is<br>equivalent to the CT Expres 3D. |
| Injection Rates for Saline | 0.1 ml/s to 10.0 ml/s | 0.1-9.9 mL/s | ulrichINJECT CT motion is<br>equivalent to the CT Expres 3D<br>related to the injection rates for<br>saline. |
| Injection Volume per Injection | 1 to 200 mL max volume of contrast<br>media per patient with a max of 400<br>mL total media (contrast and saline)<br>per patient | 10-200 mL with a max of<br>400 mL total media (contrast<br>and saline) per patient | ulrichINJECT CT motion is<br>equivalent to the CT Expres 3D<br>related to injection volume per<br>injection. |
| Flow Rate and Volume<br>Accuracy | 10-200 mL of contrast media with<br>volume accuracy of + 5%<br>Flow rate accuracy of + 5% | +/- 10% for a programmed<br>injection volume between 10<br>mL and 59 mL<br>+/- 6% for a programmed<br>injection volume between 60<br>mL and 200 mL | ulrichINJECT CT motion is<br>equivalent to the CT Expres 3D<br>related to flow rate and volume<br>accuracy with a greater flow rate<br>accuracy delivered by<br>ulrichINJECT CT motion. |
| Product Name: | ulrichINJECT CT motion<br>by ulrich Medical | CT Expres 3D Contrast<br>Media Delivery System by<br>Bracco Injeneering S.A.<br>K151048 | Comparison |
| Contrast Media Container<br>Volume | 500 mL | 200 & 500 mL | ulrichINJECT CT motion is<br>equivalent to the CT Expres 3D<br>related to contrast media<br>container volume. |
| Saline Flush | Yes | Yes | ulrichINJECT CT motion is<br>equivalent to the CT Expres 3D<br>related to saline flush. |
| Needle Size | 14-24 G | 16-24 G | ulrichINJECT CT motion is<br>equivalent to the CT Expres 3D<br>related to needle sizes |
| Injection Pause | Programmable - 0 sec to 999 sec in<br>1 sec increments | 0-400 seconds | ulrichINJECT CT motion is<br>equivalent to the CT Expres 3D<br>related to injection pause |
| Injection Protocol Storage | Yes | Yes | ulrichINJECT CT motion is<br>equivalent to the CT Expres 3D<br>related to injection protocol<br>storage |
| Priming/Venting Rate | 2 mL/s (manual) | 1.5 mL/s (manual)<br>6.0 mL/s (automatic) | ulrichINJECT CT motion is<br>equivalent to the CT Expres 3D<br>related to priming/venting rate |
| Product Name: | ulrichINJECT CT motion<br>by ulrich Medical | CT Expres 3D Contrast<br>Media Delivery System by<br>Bracco Injeneering S.A.<br>K151048 | Comparison |
| Air Detection Principle | Ultrasound | Ultrasound | ulrichINJECT CT motion is<br>identical to the CT Expres 3D<br>related to air detection principle |
| Technical Detection Limit of<br>air in tubing | 0.05 mL | 0.04 mL…
