Predicate Devices

Reference Devices

CREALIFE Anythink PACS Workstation, K131299

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard CT image reconstruction and processing algorithms, and mentions integration with a third-party PACS workstation for image processing, but does not explicitly mention or describe the use of AI or ML.

Therapeutic

No
The device is described as an imaging device intended to produce cross-sectional images for diagnosis, not for treating a condition.

Diagnostic

Yes

The device produces cross-sectional images of the body to aid in the diagnosis and treatment of various medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system includes hardware components such as the gantry, patient table, operator console, power distribution unit, X-ray tube, and detector array. It also mentions that images are acquired through the use of both hardware and software.

IVD (In Vitro Diagnostic)

Based on the provided information, the CURA 778 is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
CURA 778 Function: The CURA 778 is a Computed Tomography X-Ray System. It works by using X-rays to create cross-sectional images of the inside of the body. It does not analyze samples taken from the body.
Intended Use: The intended use is to produce images of the body for diagnosis and treatment, not to analyze biological specimens.

Therefore, the CURA 778 falls under the category of medical imaging devices, not In Vitro Diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The CURA 778 is a Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data collected at different angles and planes.

The system may include signal analysis and display equipment, patient and equipment supports, components and accessories.

The CURA 778 scanner is a whole body scanner, with cardiac and vascular X-ray Computed Tomography applications in patients of all ages.

Product codes

JAK

Device Description

The CURA 778 scanner is a medical imaging device utilizing X-ray computed tomography (CT) to obtain images of the entire body. The CURA 778 is a high performance imaging system that uses retina Solid State Detector technology to ensure high image quality. It uses ultrafast scintillator technology and application optimized algorithm to enhance image details and integrated anti-scatter grid (ASG) and A/D technology (ASIC) to maximize SNR. It produces better image quality by innovative calibration algorithms. Efficient design of the gantry helps achieve structural stability under high G-Load and optimize the air flow to guarantee long thermal stability for wide range of ambient temperature and pleasant user experience.

The primary components of this system include the gantry, patient table, operator console and power distribution unit. Patient images are acquired, through the use of both hardware and software, via a rotating X-ray tube and detector array on the opposite side. The collected data is transmitted to the operator console for reconstruction into cross-sectional images.

The CURA 778 is designed for use in a controlled clinical setting, to collect X-ray images that aid in the diagnosis and treatment of various medical conditions by a physician or similarly licensed medical professional. The CURA 778 is intended for use by an appropriately trained or licensed professional, such as a physician, CT X-ray technician, or field service engineer. This device is restricted to sale by or on the order of a physician or similarly licensed medical professional (i.e. by prescription only).

The CURA 778 system is a stationary full gantry device. The gantry is comprised of several subsystems, including the X-ray tube, pre-patient collimator, detector array, cooling fans, power distribution unit, high voltage inverter, high voltage generator, data collection board (DCB) electronics and support electronics. The gantry is organized into two distinct sections, the stator (stationary elements) and the rotor (rotating elements). Slip rings are utilized to facilitate the transfer of electrical power and data between the gantry rotor and stator.

The CURA 778 system software implements many of the CURA 778 Whole Body system scanner. Among the functions performed by the software are:

Entering and editing protocol, patient, and scan parameter data
Initiating scans, executing scan protocols, monitoring status, and responding to faults ●
Collecting image data and generating image views
Image viewing (3d reconstruction, MPR, CPR, MIP)
Image analysis (ROI)
Reporting and image filming
Exporting data for external viewing or printing
Performing calibrations
Performing diagnostics
Dose modulation feature (imA)
. Integrate a 30 party device for cardiac image processing, CREALIFE Anythink PACS Workstation, K131299 (510(k) number).

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray Computed Tomography (CT)

Anatomical Site

Body (including head), cardiac, vascular

Indicated Patient Age Range

patients of all ages

Intended User / Care Setting

Intended for use by an appropriately trained or licensed professional, such as a physician, CT X-ray technician, or field service engineer, in a controlled clinical setting.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The CURA 778 system was tested to ensure it functions as intended throughout the design process. The executed test documents were reviewed for accuracy and appropriateness as part of the design of the system. Additionally, evidence of dosimetric testing has been provided within this submission and was performed to ensure the allowable limits set forth by FMI Medical Systems are accurate and achievable by the system. Sample clinical images have been provided within the submission. The image quality has been evaluated by a certified radiologist.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K160743, K173076

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

0

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized emblem with text encircling it. To the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in bold blue letters, with "ADMINISTRATION" written below in a smaller font.

FMI Medical Systems, Inc. % Dazhuang Meng Senior Director of Product Development 29001 Solon Road, Unit A SOLON OH 44139

March 5, 2020

Re: K192590

Trade/Device Name: CURA 778 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: November 5, 2019 Received: January 21, 2020

Dear Dazhuang Meng:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

1

https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192590

Device Name CURA 778

Indications for Use (Describe)

The CURA 778 is a Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data collected at different angles and planes.

The system may include signal analysis and display equipment supports, components and accessories.

The CURA 778 scanner is a whole body scanner, with cardiac and vascular X-ray Computed Tomography applications in patients of all ages.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 5 - 510(k) Summary

K192590

| 510(k) Submitter: 29001 Solon Road, Unit A,
Solon, Ohio 44139, USA
Phone: +1 440-600-5952
Email: huang.meng@fmimedical.com" target="_blank" rel="noopener noreferrer" class="text-primary hover:underline break-words">dazhuang.meng@fmimedical.com |
--------------------------------------------------------------------------------------------------------------------------------------------------|
| Dazhuang Meng, Senior Director of Product Development |
| FMI Medical Systems Inc.
huang.meng@fmimedical.com" target="_blank" rel="noopener noreferrer" class="text-primary hover:underline break-words">dazhuang.meng@fmimedical.com |
|
| CURA 778 |
| Computed tomography x-ray system |
| Radiology |
|
| 21 CFR 892.1750 |
|
|
| Philips Ingenuity CT |
| K160743 |
| 21 CFR 892.1750 |
| Computed tomography x-ray system |
|
|
| Radiology |
| Philips Medical Systems (Cleveland), Inc. |
|

The CURA 778 scanner is a medical imaging device utilizing X-ray computed tomography (CT) to obtain images of the entire body. The CURA 778 is a high performance imaging system that uses retina Solid State Detector technology to ensure high image quality. It uses ultrafast scintillator technology and application optimized algorithm to enhance image details and integrated anti-scatter grid (ASG) and A/D technology (ASIC) to maximize SNR. It produces better image quality by innovative calibration algorithms. Efficient design of the gantry helps achieve structural stability under high G-Load and optimize the air flow to guarantee long thermal stability for wide range of ambient temperature and pleasant user experience.

4

The primary components of this system include the gantry, patient table, operator console and power distribution unit. Patient images are acquired, through the use of both hardware and software, via a rotating X-ray tube and detector array on the opposite side. The collected data is transmitted to the operator console for reconstruction into cross-sectional images.

The CURA 778 is designed for use in a controlled clinical setting, to collect X-ray images that aid in the diagnosis and treatment of various medical conditions by a physician or similarly licensed medical professional. The CURA 778 is intended for use by an appropriately trained or licensed professional, such as a physician, CT X-ray technician, or field service engineer. This device is restricted to sale by or on the order of a physician or similarly licensed medical professional (i.e. by prescription only).

The CURA 778 system is a stationary full gantry device. The gantry is comprised of several subsystems, including the X-ray tube, pre-patient collimator, detector array, cooling fans, power distribution unit, high voltage inverter, high voltage generator, data collection board (DCB) electronics and support electronics. The gantry is organized into two distinct sections, the stator (stationary elements) and the rotor (rotating elements). Slip rings are utilized to facilitate the transfer of electrical power and data between the gantry rotor and stator.

The CURA 778 system software implements many of the CURA 778 Whole Body system scanner. Among the functions performed by the software are:

Entering and editing protocol, patient, and scan parameter data
Initiating scans, executing scan protocols, monitoring status, and responding to faults ●
Collecting image data and generating image views
Image viewing (3d reconstruction, MPR, CPR, MIP)
Image analysis (ROI)
Reporting and image filming
Exporting data for external viewing or printing
Performing calibrations
Performing diagnostics
Dose modulation feature (imA)
. Integrate a 30 party device for cardiac image processing, CREALIFE Anythink PACS Workstation, K131299 (510(k) number).

Device Safety and Risk Management:

The CURA 778 system device safety and risk management activities are documented in an associated Risk Management Plan. This document defines that the system complies with the following safety standards:

. IEC 60601-1, Medical electrical equipment
IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
. IEC 60601-2-44, Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography

5

IEC 60601-1-3, Medical electrical equipment Part 1-3: General requirements for basic . safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
IEC 60825-1, Safety of laser products - Part 1: Equipment classification and requirements
. IEC 61223-3-5, Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment
IEC 62366-1, Medical devices -- Part 1: Application of usability engineering to medical devices

The Risk Management Plan has also documented the assessment of risk utilizing ISO standard ISO 14971:2012, Application of Risk Management to Medical Devices. The CURA 778 system has been assessed and evaluated for risk, via defined Criteria for Risk Acceptability, through an approved Risk Management Matrix.

The following reference standards and guidance documents were utilized in the design and development of the CURA 778 system:

. ISO 14971:2012, Medical devices. Application of risk management to medical devices
ISO 13485:2016, Application of quality management system for the design and manufacture of medical devices
21 CFR 820, Quality System Regulation
21 CFR 1020.33, Computed Tomography Equipment ●
21 CFR 1040.10, Laser Products (IEC 60825-1)
21 CFR 1020.30, Performance Standard for Diagnostic X-Ray Systems
IEC 62304, Medical Device Software – Software life cycle processes

In addition, the CURA 778 system software documentation has been submitted according to a moderate level of concern utilizing the FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued 05/11/05).

Performance Testing:

The CURA 778 system was tested to ensure it functions as intended throughout the design process. The executed test documents were reviewed for accuracy and appropriateness as part of the design of the system. Additionally, evidence of dosimetric testing has been provided within this submission and was performed to ensure the allowable limits set forth by FMI Medical Systems are accurate and achievable by the system. Sample clinical images have been provided within the submission. The image quality has been evaluated by a certified radiologist.

Indications for Use:

The CURA 778 is a Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data collected at different angles and planes.

The system may include signal analysis and display equipment, patient and equipment supports, components and accessories.

6

The CURA 778 scanner is a whole body scanner, with cardiac and vascular X-ray Computed Tomography applications in patients of all ages.

Substantial Equivalence:

FMI Medical Systems Inc. is citing substantial equivalence of the CURA 778 system to the 510(k), K160743, predicate device Philips Ingenuity CT. Second substantial equivalence to the 510(k), K173076, predicate device CURA 16.

Substantial Equivalence Statement:

FMI Medical Systems Inc. is citing substantial equivalence of the CURA 778 System to the Philips Ingenuity CT. Regulatory citations for the Philips Ingenuity CT are as follows:

Predicate Device:	Philips Ingenuity CT
Predicate 510(k):	K160743
Regulation:	21 CFR 892.1750
Class:	II
Product Code:	JAK
Panel:	Radiology
Manufacturer:	Philips Medical Systems (Cleveland), Inc.

The CURA 778 System is substantially equivalent in design, intended use, indications for use and technology with the currently marketed predicate. There are no significant differences in materials, energy source, or technological characteristics. Both the proposed system and the predicate are computed tomography scanners that support visualization tools. The design and fundamental scientific technology of both systems compare favorably.

The CURA 778 System and the predicate both produce images of the head and body by computer reconstruction of X-ray transmission data. The subsystems (patient supports, generator, x-ray tube and detector) of both devices compare favorably, with only minor differences that do not affect safety and efficacy. This is supported by a comparison of system component characteristics and specifications in the table above.

The CURA 778 System is as safe and effective as the predicate device, as demonstrated by successful completion of verification and validation testing, risk management activities and conformance to international standards. It is the conclusion of FMI Medical Systems that the CURA 778 System is substantially equivalent to the predicate, Philips Ingenuity CT, and that there are no significant differences that raise new issues of safety or efficacy.

Additional comparisons are listed in the table below.

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| Characteristics –
Components /
Specifications | Predicate:
Ingenuity CT | Proposed:
CURA 778 | Comments |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The Ingenuity CT is a
Computed Tomography X-
Ray System intended to
produce images of the head
and body by computer
reconstruction of x-ray
transmission data taken at
different angles and planes.

These devices may include
signal analysis and display
equipment, patient and
equipment supports,
components and
accessories.

The Ingenuity CT is indicated
for head, whole body, cardiac
and
vascular X-ray Computed
Tomography applications in
patients of all ages.

These scanners are intended
to be used for diagnostic
imaging and for low dose CT
lung cancer | The CURA 778 is a Computed
Tomography X-Ray System that
is intended to produce cross-
sectional images of the body by
computer reconstruction of X-ray
transmission data collected at
different angles and planes.

The system may include signal
analysis and display equipment,
patient and equipment supports,
components and accessories.

The CURA 778 scanner is a
whole body scanner, with
cardiac and vascular X-ray
Computed Tomography
applications in patients of all
ages. | The CURA 778 proposed
indications for use are
consistent with the predicate.
Both systems are capable of
imaging in axial and spiral
planes, at multiple angles.
Indicates the potential for
signal analysis and display
equipment, patient and
equipment supports,
components and accessories.
Whole body scanner, with
cardiac and vascular X-ray
Computed Tomography
applications in patients of all
ages.

8

9

10

FMI Medical Systems Inc. is citing second substantial equivalence of the CURA 778 system to the CURA 16. Regulatory citations for the CURA 16 are as follows:

Predicate Device:	CURA 16
Predicate 510(k):	K173076
Regulation:	21 CFR 892.1750
Class:	II
Product Code:	JAK
Panel:	Radiology
Manufacturer:	FMI Medical Systems, Inc.

The CURA 778 system is substantially equivalent (with some enhancement) in design, intended use, indications for use and technology with the currently marketed predicate. There are no significant differences in materials, or technological characteristics. Both the proposed system and the predicate are computed tomography scanners that support visualization tools. The design and fundamental scientific technology of both systems compare favorably, except the energy source, detector coverage. On CURA 778, the energy source has bigger capacity, and the detector has larger coverage, which enable more patient through output, lower dose, and advanced features (for example: cardiac, vascular, ... ...)

The submission K192590 CURA 778 CT scanner device, is based on the mechanical and control system architecture of the previous one (CURA 16, K173076), with below enhancement:

	CURA 16	CURA 778
Tube and generator	5.3MHU	8MHU	Enhanced
Flying focal spot (Z direction)	No	Yes	Enhanced
Detector physical slices	16	64	Enhanced
Detector coverage (mm)	18.56	40	Enhanced
Rotation speed (second/rotation)	0.5	0.39	Enhanced
Motion control system			Same
Mechanical structure			Same
Software and Recon architecture			Same
Cardiac application	No	Yes	Enhanced

11

The CURA 778 system and the predicate both produce images of the head and body by computer reconstruction of X-ray transmission data. The subsystems (patient supports, generator, x-ray tube and detector) of both devices comparable or has similar architecture/technology behind them, with only minor differences that do not affect safety and efficacy. This is supported by a comparison of system component characteristics and specifications in the table above.

The CURA778 system is as safe and effective as the predicate device, as demonstrated by successful completion of verification and validation testing, risk management activities and conformance to international standards. It is the conclusion of FMI Medical Systems that the CURA 778 system is substantially equivalent (with some enhancement) to the predicate, CURA 16, and there are no significant differences that raise new issues of safety or efficacy.

| Characteristics -
Components /
Specifications | Predicate:
CURA 16 | Proposed:
CURA 778 | Comments |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The CT16 is a Computed
Tomography X-Ray System
that is intended to produce
cross-sectional images of the
body by computer
reconstruction of X-ray
transmission data collected
at different angles and
planes.
The system may include
signal analysis and display
equipment, patient and
equipment supports,
components and
accessories.
The system is suitable for all
patients. | The CURA 778 is a Computed
Tomography X-Ray System that
is intended to produce cross-
sectional images of the body by
computer reconstruction of X-ray
transmission data collected at
different angles and planes.
The system may include signal
analysis and display equipment,
patient and equipment supports,
components and accessories.
The CURA 778 scanner is a
whole body scanner, with
cardiac and vascular X-ray
Computed Tomography
applications in patients of all
ages. | The CURA 778 proposed
indications for use are
consistent with the predicate.
Both systems are capable of
imaging in axial and spiral
planes, at multiple angles.
Indicates the potential for
signal analysis and display
equipment, patient and
equipment supports,
components and accessories.
In addition, the CURA 778 is
also indicated for cardiac and
vascular X-ray Computed
Tomography applications in
patients of all ages. |
| Design | | | |
| Application | Full body(includes head) | Full body (includes head) | Compares favorably |
| Scan regimen | Continuous rotation | Continuous rotation | Compares favorably |
| Scan modes | Scout(Surview) | Scout (Surview) | Compares favorably |
| | Helical | Helical | |
| | Axial | Axial | |
| | Multi-Axial | Multi-Axial(Step and Shoot) | |
| Gantry | | | |
| Gantry aperture
(bore) size | 70 cm | 70 cm | Compares favorably |
| Gantry tilt | +/-30 degrees | +/-30 degrees | Compares favorably |
| Focus - | 558mm | 558 mm | Compares favorably |
| Characteristics –
Components /
Specifications | Predicate:
CURA 16 | Proposed:
CURA 778 | Comments |
| isocenter distance | 948.40 mm | 950.25 mm | Detector distance for the
CURA 778 is 1.58 mm length
than the predicate. This
difference does not affect
safety or efficacy. |
| Focus – detector
distance | 948.40 mm | 950.25 mm | Detector distance for the
CURA 778 is 1.58 mm length
than the predicate. This
difference does not affect
safety or efficacy. |
| Rotation times | 0.5, 0.75, 1.0, 1.5, 2.0
seconds | 0.39, 0.5, 0.75, 1.0, 1.5, 2.0
seconds | Rotation time capability for
CURA 778, 5 out of 6 specific
settings (0.5, 0.75, 1.0, 1.5,
and 2.0 seconds) are identical
to the predicate. 0.39 second
is the enhancement for this 64
row/128 slices machine. This
does not affect safety or
efficacy. |
| Patient Support / Couch / Table | | | |
| Patient supports | Included | Included | Compares favorably |
| Patient table scan
range | 1700 mm | 1700 mm | Compares favorably |
| Table Z-position
accuracy | +/- 0.25 mm | +/- 0.25 mm | Compares favorably |
| Table longitudinal
speed | 1 to 150 mm / second | Up to 200 mm / second | The maximum speed
capability of the CURA 778 is
50 mm/sec greater than the
predicate. This difference does
not affect safety or efficacy. |
| Table maximum load
capacity | 205 kg | 205 kg | Compares favorably |
| Generator | | | |
| Generator power
rating | 50 kW | 80 kW | Compares favorably |
| kVp settings | 80, 110,130 kV | 80, 100, 120, 140 kV | CURA 778 as similar kV setting
compare with CURA 16. This
difference does not affect
safety or efficacy. |
| mA range (step size) | 10-420 mA (10 mA steps) | 10 – 660 mA (10 mA steps) | The mA range for the CURA
778 (10 – 660 mA) is bigger
than the predicate (10 – 420
mA), while has the same step
size (10 mA).
Bigger range enable more
patients scan capacity and |
| Characteristics –
Components /
Specifications | Predicate:
CURA 16 | Proposed:
CURA 778 | Comments |
| | | | some specific application
protocols.
These differences do not
affect safety or efficacy. |
| X ray tube | | | |
| Focal spot size | 0.7 x 1.2 mm (small)
1.2 x 1.2 mm (large) | 0.6 mm x 1.2 mm (small)
1.1 mm x 1.2 mm (large) | The focal spot sizes for the
CURA 778 specs are smaller
than those of the predicate.
This difference does not affect
safety or efficacy. |
| Anode effective heat
capacity | 5.3 MHU | 8.0 MHU | CURA 778 is bigger than the
predicate.
Bigger heat capacity enable
more patients scan possibility
and some specific application
protocols.
These differences do not
affect safety or efficacy. |
| X-ray tube,
maximum applied
power | 420 mA | 660 mA | X-ray tube maximum applied
power for the CURA 778 is 240
mA bigger than the predicate.
This difference does not affect
safety or efficacy. |
| Detector (DMS or Data Management System) | | | |
| Detectors | Solid-state ultra-high speed
rare earth ceramic
scintillator | Solid-state GOS | Compares favorably |
| Slices | 16 slices | 128 slices | CURA 778 is a 128 slices
product, while CURA 16 is a 16
slices one. This difference
does not affect safety. 128
slices can have more features,
for example cardiac. |
| Coverage | Maximum 18.56 mm | Maximum 40 mm | Coverage for the CURA 778 is
21.44 mm wider than the
predicate. This difference does
not affect safety. With bigger
coverage detector, product
can have more features, for
example cardiac. |
| Axial
Slice thickness (mm)
(image
reconstruction) | 0.58 mm
1.16 mm
2.32 mm
4.64 mm
9.28 mm
18.56 mm | 0.5 mm
0.625 mm
1.25 mm
2.5 mm
5 mm
10 mm | For reconstruction of axial
images, the range of and
number of options for slice
thickness are similar between
the CURA 778 and the
predicate. Multiple options |
| Characteristics –
Components /
Specifications | Predicate:
CURA 16 | Proposed:
CURA 778 | Comments |
| | | | provide the user with the
ability to select parameters
that support required image
quality and capture the target
area of interest. The
differences do not affect
safety or efficacy. |
| Helical
Slice thickness (mm)
(image
reconstruction) | 0.5 mm
1.0 mm
1.5 mm
2.0 mm
2.5 mm
3.0 mm
4.0 mm
5.0 mm
6.0 mm
7.0 mm
8.0 mm
9.0 mm
10.0 mm | 0.5 mm
0.625 mm
1mm
1.25 mm
2mm
2.5 mm
3mm
4mm
5 mm
6mm
7mm
8mm
9mm
10 mm | For reconstruction of helical
images, the range of and
number of options for slice
thickness are similar between
the CURA 778 and the
predicate. Multiple options
provide the user with the
ability to select parameters
that support required image
quality and capture the target
area of interest. The
differences do not affect
safety or efficacy. |
| Scan field | 500 mm | 250 mm, 500 mm | Compares favorably |
| Image matrix | 512 x 512 | 512 x 512
1,024 x 1,024 (Optional) | The image matrix of the CURA
778 has more option than the
predicate. This difference does
not affect safety or efficacy. |

Additional comparisons are listed in the table below.

12

13

14