Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on extracting and comparing predefined values based on established standards (NEMA XR-25, XR-29, AAPM guidelines). There is no mention of learning from data, adaptive algorithms, or any terminology typically associated with AI/ML. The "OTS" mentioned in testing appears to be an "Off-The-Shelf" component for image processing, not an AI/ML system.

Therapeutic

No
The device provides dose check features and alerts for CT systems, but it does not directly treat or diagnose a disease or condition, which is the definition of a therapeutic device.

Diagnostic

No

The device is designed to monitor and alert on CT dose levels, not to diagnose a patient's medical condition. It works by checking CTDI values against predefined thresholds to ensure patient safety regarding radiation exposure.

SaMD (Software as a Medical Device)

No

The device description explicitly states that Z-DOSE29 utilizes a relay to disable scanning in the event of an Alert. A relay is a hardware component, indicating the device is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Z-DOSE29 Dose Check system is not an IVD (In Vitro Diagnostic) 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.
Z-DOSE29 Function: The Z-DOSE29 system works with Computed Tomography (CT) systems. It extracts dose information (CTDI values) from the CT scanner's output, compares it to predefined thresholds, and provides notifications and alerts to the CT operator. It does not analyze any biological specimens from the patient.
Intended Use: The intended use is to provide dose check features for CT systems, focusing on radiation dose management during imaging procedures.
Device Description: The description clearly states it receives DICOM images and extracts CTDI values, which are related to the radiation dose delivered by the CT scanner, not biological markers from the patient.

Therefore, the Z-DOSE29 system falls under the category of a medical device used in conjunction with imaging equipment, but it does not meet the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Z-DOSE29 Dose Check system is intended to provide dose check features to Computed Tomography systems. Z-DOSE29 software extracts CTDI values from CT host computer's screen, compares it to predefined thresholds, and sends notification and alert messages to the CT scanner display monitor prior to scanning.

Product codes

JAK

Device Description

Z-DOSE29 Dose Check provides the Dose Check feature to CT scanners as specified by the NEMA XR-25 standard and the Dose Check feature of NEMA XR-29*. This includes both Dose Notifications (for individual series) and Dose Alerts (for accumulated dose).

The Z-DOSE29 Dose Check software, which is installed on a remote computer that resides on the same local area network as the CT host computer, receives DICOM images from the CT host computer. The software captures CTDI values for each prescribed CT series, compares the values to AAPM dose check guideline (version 1.0) values and displays notification message(s) on the CT scanner operator's console. The Z-DOSE29 Dose Check software also adds the CTDI values from the individual series and displays alert message(s) on the CT scanner operator's console if the accumulated CTDI value exceeds a predefined ALERT threshold.

*NEMA XR-29 incorporates NEMA XR-25 Dose Check feature

In the event of an Alert, and in addition to displaying the alert message to the CT operator, Z-DOSE29 utilizes a relay to disable scanning until a correct password is inputted by the CT operator.

The Z-DOSE29 Dose Check software also records CTDI values and CT exam information into a local a database. Information in the database can be accessed by authorized users via a web browser.

The Z-DOSE29 Dose Check software runs on a Windows operating system 10 with a .net framework 4.0 or higher version.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Computed Tomography (CT)

Anatomical Site

Not Found

Indicated Patient Age Range

Adult and Pediatric (Head and Body)

Intended User / Care Setting

Not Found

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

Testing performed on OTS using more than 2400 image data sets indicated that OTS accurately extracts CTDI information from more than 99% of the images.
Z-DOSE29 was verified to meet system requirement specifications (SRS) on four different CT scanners from different manufacturers (GE Light Speed 32, Siemens Sensation 16, Philips Brilliance 64, Toshiba Aquilion 64) and lower level requirements were verified on 9 different systems.

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

The software successfully captured CTDI values for Adult Head, Adult Body, Pediatric Head, Pediatric Body, and Perfusion exams, compared them to AAPM Dose Check Guidelines suggested threshold values, and notified the user by displaying dialogue boxes when the values exceeded the thresholds.
The software accurately calculated total CTDI values from each series, compared the accumulated values to AAPM Dose Check Guidelines suggested threshold values, and alerted the user by displaying dialogue boxes when the accumulated values exceeded the thresholds.
The software correctly used relay hardware to disable the system from scanning when an alert occurred.
The software successfully recorded and reported CTDI and exam information.

All observed outcomes matched the expected outcomes, resulting in a "PASS" for all tested requirements.

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

Not Found

Predicate Device(s)

K143400, K153331

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 28, 2017

Zetta Medical Technologies, LLC. Main M. Ghazal President 1313 Ensell Road Lake Zurich. Illinois 60047

Re: K170273

Trade/Device Name: Z-DOSE29 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: January 30, 2017 Received: January 30, 2017

Dear Main Ghazal:

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 (reporting of medical device-

Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, overlapping each other to create a sense of depth and unity.

1

related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael D. O'Hara

For

Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K170273

Device Name Z-DOSE29

Indications for Use (Describe)

Z-DOSE29 Dose Check system is intended to provide dose check features to Computed Tomography systems. Z-DOSE29 software extracts CTDI values from CT host computer's screen, compares it to predefined thresholds, and sends notification and alert messages to the CT scanner display monitor prior to scanning.

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

☒ Registration Use (Part 81 CFR 98.6 Subpart D)	☐ On-Site Combustion Use (81 CFR 98.6 Subpart C)
--------------------------------------------------------------------------------------------------	--------------------------------------------------

| X | Prescription Use (Part 21 CFR 801 Subpart D)

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

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3

510(k) Summary of Safety and Effectiveness

1. Applicant & Submitted By: Zetta Medical Technologies, LLC. 1313 Ensell Road, Lake Zurich, IL 60047 Phone: (847) 550-9990 Fax: (847) 550-9994 Contact Person: Main M. Ghazal, President Date Prepared: January 22nd 2017
1. Identification of the Device: Trade Name: Z-DOSE29 Common Name: Computed Tomography X-ray system Classification Name: 21 CFR, 892.1750, JAK, Radiology
1. Predicate Device:

| Manufacturer | Trade
name/model | 510(k)
Number | Regulation
Number | Product
code |
|--------------|----------------------------------|------------------|----------------------|-----------------|
| Siemens | syngo ® VA48
(SOMARIS/7 VA48) | K143400 | 892.1750 | JAK |
| Medic Vision | SafeCT-29 | K153331 | 892.1750 | JAK |

1. Indications for Use:
  Z-DOSE29 Dose Check system is intended to provide dose check features to Computed Tomography systems. Z-DOSE29 software extracts CTDI values from CT host computer's screen, compares it to predefined thresholds, and sends notification and alert messages to the CT scanner display monitor prior to scanning.
1. Device Description:
  Z-DOSE29 Dose Check provides the Dose Check feature to CT scanners as specified by the NEMA XR-25 standard and the Dose Check feature of NEMA XR-29*. This includes both Dose Notifications (for individual series) and Dose Alerts (for accumulated dose).

The Z-DOSE29 Dose Check software, which is installed on a remote computer that resides on the same local area network as the CT host computer, receives DICOM images from the CT host computer. The software captures CTDI values for each prescribed CT series, compares the values to AAPM dose check guideline (version 1.0) values and displays notification message(s) on the CT scanner operator's console. The Z-DOSE29 Dose Check software also adds the CTDI values from the individual series and displays alert message(s) on the CT scanner operator's console if the accumulated CTDI value exceeds a predefined ALERT threshold.

*NEMA XR-29 incorporates NEMA XR-25 Dose Check feature

4

In the event of an Alert, and in addition to displaying the alert message to the CT operator, Z-DOSE29 utilizes a relay to disable scanning until a correct password is inputted by the CT operator.

The Z-DOSE29 Dose Check software also records CTDI values and CT exam information into a local a database. Information in the database can be accessed by authorized users via a web browser.

The Z-DOSE29 Dose Check software runs on a Windows operating system 10 with a .net framework 4.0 or higher version.

1. Substantial Equivalence Table
  The subject device Z-DOSE29 Dose Check System is substantially equivalent to the two predicate devices, Syngo® VA48 and SafeCT-29. Detailed comparison of Z-DOSE29 with SingoVA48 and SafeCT-29 is listed in Table-1.

	Table -1: Comparison among Z-DOSE29, Syngo® VA48 and SafeCT-29 CT Dose Check
--	------------------------------------------------------------------------------

		Systems
Characteristics	Z-DOSE29	Syngo® VA48	SafeCT-29
Indications for Use	Z-DOSE29 Dose
Check system is
intended to provide
dose check features
to Computed
Tomography
systems. Z-DOSE29
software extracts
CTDI values from
CT host computer's
screen, compares it
to predefined
thresholds, and
sends notification
and alert messages
to the CT scanner
display monitor
prior to scanning.	The Siemens
SOMATOM Definition
AS/ AS+ (Project P46)
systems are intended
to produce cross-
sectional images of the
body by computer
reconstruction of x-ray
transmission data
from either the same
axial plane taken at
different angles or
spiral planes* taken at
different angles.
(*spiral planes: the
axial planes resulted
from the continuous
rotation of detectors
and x-ray tube, and
the simultaneous
translation of the
patient.)	The SafeCT-29 is
intended for providing
Computed Tomography
Dose Check feature to
Computed Tomography
X-ray systems.
The SafeCT-29 is
specifically indicated
for providing the
Computed Tomography
Dose Check feature
which notifies and
alerts the CT equipment
operators, prior to a
scan, if the estimated
dose index is above the
predefined thresholds,
for CT scanners not
equipped with this
functionality. The
device is indicated for
use by professional
personnel.
Data Inputs	Z-DOSE29 is a
software based
solution to extract
CTDI information
from CT computer's
screen through a	Host CT Digital Data
directly interfaced by
the device software.	The SafeCT-29 uses its
own input separate
hardware: The device is
interfaced to the CT
screen via a video
splitter that provides a
copy of the CT screen in
Characteristics	Z-DOSE29	Syngo® VA48	SafeCT-29
	local area network
(LAN) connection.		real-time. The CT
screen data is captured
by grabbing and
digitizing the video
signal. The captured
data is interpreted by
OCR software.
Scan Controls	Software and
hardware	Software	Software & hardware
Dose Notification
for individual
series	Designed to
perform the "Dose
Notification"
feature of NEMA
XR-25	Designed to perform
the "Dose
Notification" feature
of NEMA XR-25	Unknown
Dose Alert for
accumulated
CTDI	Designed to
perform the "Dose
Alert" feature of
NEMA XR-25	Designed to perform
the "Dose Alert"
feature of NEMA XR-
25	The software extracts
accumulated CTDIvol
per Z axis location from
the CT screen whenever
such information is
displayed by the
scanner. For scanners
that do not present
such information, the
accumulated CTDIvol is
calculated by the
SafeCT-29 software.
The calculation follows
the AAPM guidelines
and assumes "worst
case scenario" (i.e.
calculated CTDIvol may
be higher than the
actual value) in order to
prevent over-the-limit
scans. The SafeCT-29
assumes that each z-
axis position gets the
displayed maximum
CTDIvol value, and
calculates the
accumulated CTDIvol
accordingly.
Display	Host CT Screen	Host CT Screen	The SafeCT-29 has its
own external display
monitor as a separate
hardware. SafeCT-29.
Characteristics	Z-DOSE29	Syngo® VA48	SafeCT-29
			generates an audio
alert to ensure the user
is aware of notifications
and warnings displayed
on the SafeCT-29
display monitor.
Man machine
interface	Host CT keyboard &
mouse	Host CT keyboard &
mouse	SafeCT-29 own
dedicated keyboard &
mouse
Record data
output	Data is saved in a
local database,
which can be
accessed by
authorized users
via a web browser.
Data can also be
exported to excel
files.	Not known	Data is saved in the
Device's internal
memory
and can be exported
with a USB memory
stick
Processor
hardware	Off-the-shelf
computer	Host CT Processor	Dedicated Off-the-shelf
processor and controls

5

6

Z-DOSE29 CT Dose Check system has similar indications for use as predicate device. The main difference is that the predicate devices employ either same CT host computer or a separate computer, that receive video signal from CT host screen for notifications, while Z-DOSE29 uses a remote computer on the same LAN as CT host computer for notifications and alerts. Performance testing, along with verification and validation activities demonstrate that Z-DOSE29 is as safe and effective as predicate device.

1. Performance Testing:
  Z-DOSE29 has been designed, verified and validated in compliance with FDA 21 CFR Part 820 requirements. Z-DOSE29 software uses off-the-shelf software (OTS) to capture and extract CTDI information from CT host computer. Testing performed on OTS using more than 2400 image data sets indicated that OTS accurately extracts CTDI information from more than 99% of the images. The CT operator can manually input the CTDI values into the software in the event the software doesn't read the correct CTDI value. Z-DOSE29 was verified to meet system requirement specifications (SRS) on four different CT scanners from different manufacturers (test results summary shown in Table-2 below) and lower level requirements were verified on 9 different systems.

Reference Guidance Documents

· National Electrical Manufacturers Association, "NEMA Standards Publication XR 25-2010 Computed Tomography Dose Check"

· National Electrical Manufacturers Association, "NEMA Standards Publication XR 29-2013 Standard Attributes on CT Equipment Related to Dose Optimization and Management" Section 2.3
· "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11 2005

7

"Guidance on Off-the-Shelf Software Use in Medical Devices" September 9, 1999
"Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" October 2, 2014

| Requirement | Expected outcome | Scanners used for
testing | Observed outcome | Test
result | |
|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| SRS.001
Notification
during Adult
Head exam | The software captures
the CTDI value for
Adult Head and
compares it to AAPM
Dose Check
Guidelines suggested
threshold value
(Default Value). If the
value exceeds the
threshold value, the
software notifies the
user by displaying a
dialogue box. The
dialogue box contains
both captured CTDI
value as well as the
threshold value
applied. The threshold
value is configurable
by the user in a text
file. | GE Light Speed 32;
Siemens Sensation 16;
Philips Brilliance 64;
Toshiba Aquilion 64; | The software
captured the CTDI
value for Adult
Head and compared
it to AAPM Dose
Check Guidelines
suggested threshold
value (Default
Value). If the value
exceeded the
threshold value, the
software notified the
user by displaying a
dialogue box. The
dialogue box
contained both
captured CTDI
value as well as the
threshold value
applied. The
threshold value is
configurable by the
user in a text file. | PASS | |
| SRS.001
Notification
during Adult
Body exam | The software captures
the CTDI value for
Adult Body and
compares it to AAPM
Dose Check
Guidelines suggested
threshold value
(Default Value). If the
value exceeds the
threshold value, the
software notifies the
user by displaying a
dialogue box. The
dialogue box contains
both captured CTDI
value as well as the
threshold value | GE Light Speed 32;
Siemens Sensation 16;
Philips Brilliance 64;
Toshiba Aquilion 64; | The software
captured the CTDI
value for Adult
Body and compared
it to AAPM Dose
Check Guidelines
suggested threshold
value (Default
Value). If the value
exceeded the
threshold value, the
software notified the
user by displaying a
dialogue box. The
dialogue box
contained both
captured CTDI
value as well as the
threshold value | PASS | |
| Requirement | Expected outcome | Scanners used for testing | Observed outcome | Test result | |
| | applied. The threshold
value is configurable
by the user in a text
file. | | value as well as the
threshold value
applied. The
threshold value is
configurable by the
user in a text file. | | |
| SRS.001
Notification
during
Pediatric Head
exam | The software captures
the CTDI value for
Pediatric Head and
compares it to AAPM
Dose Check
Guidelines suggested
threshold value
(Default Value). If the
value exceeds the
threshold value, the
software notifies the
user by displaying a
dialogue box. The
dialogue box contains
both captured CTDI
value as well as the
threshold value
applied. The threshold
value is configurable
by the user in a text
file. | GE Light Speed 32;
Siemens Sensation 16;
Philips Brilliance 64;
Toshiba Aquilion 64; | The software
captured the CTDI
value for Pediatric
Head and compared
it to AAPM Dose
Check Guidelines
suggested threshold
value (Default
Value). If the value
exceeded the
threshold value, the
software notified the
user by displaying a
dialogue box. The
dialogue box
contained both
captured CTDI
value as well as the
threshold value
applied. The
threshold value is
configurable by the
user in a text file. | PASS | |
| | SRS.001
Notification
during
Pediatric Body
exam | The software captures
the CTDI value for
Pediatric Body and
compares it to AAPM
Dose Check
Guidelines suggested
threshold value
(Default Value). If the
value exceeds the
threshold value, the
software notifies the
user by displaying a
dialogue box. The
dialogue box contains
both captured CTDI
value as well as the | GE Light Speed 32;
Siemens Sensation 16;
Philips Brilliance 64;
Toshiba Aquilion 64; | The software
captured the CTDI
value for Pediatric
Body and compared
it to AAPM Dose
Check Guidelines
suggested threshold
value (Default
Value). If the value
exceeded the
threshold value, the
software notified the
user by displaying a
dialogue box. The
dialogue box
contained both | |
| | | threshold value | | captured CTDI | |
| | Requirement | Expected outcome | Scanners used for testing | Observed outcome | Test result |
| | SRS.001
Notification
during
Perfusion
exam | threshold value
applied. The threshold
value is configurable
by the user in a text
file.

The software captures
the CTDI value for
Perfusion and
compares it to AAPM
Dose Check
Guidelines suggested
threshold value
(Default Value). If the
value exceeds the
threshold value, the
software notifies the
user by displaying a
dialogue box. The
dialogue box contains
both captured CTDI
value as well as the
threshold value
applied. The threshold
value is configurable
by the user in a text
file. | GE Light Speed 32;
Siemens Sensation 16;
Philips Brilliance 64;
Toshiba Aquilion 64; | captured CTDI
value as well as the
threshold value
applied. The
threshold value is
configurable by the
user in a text file.

The software
captured the CTDI
value for Perfusion
and compared it to
AAPM Dose Check
Guidelines
suggested threshold
value (Default
Value). If the value
exceeded the
threshold value, the
software notified the
user by displaying a
dialogue box. The
dialogue box
contained both
captured CTDI
value as well as the
threshold value
applied. The
threshold value is
configurable by the
user in a text file. | |
| SRS.002
Alert if total
CTDI exceeds
threshold | The software
calculates total CTDI
value from each series
and compares the
accumulated value to
AAPM Dose Check
Guidelines suggested
threshold value
(Default Value). If the
accumulated value
exceeds the threshold
value, the software
alerts the user by
displaying a dialogue | GE Light Speed 32;
Siemens Sensation 16;
Philips Brilliance 64;
Toshiba Aquilion 64; | The software
calculated total
CTDI value from
each series and
compared the
accumulated value
to AAPM Dose
Check Guidelines
suggested threshold
value (Default
Value). If the
accumulated value
exceeded the
threshold value, the
software alerted the | PASS | |
| Requirement | Expected outcome | Scanners used for
testing | Observed outcome | Test
result | |
| | | | | | |
| | contains both
accumulated CTDI
value as well as the
threshold value
applied. The threshold
value is configurable
by the user in a text
file. | | user by displaying a
dialogue box. The
dialogue box
contained both
accumulated CTDI
value as well as the
threshold value
applied. The
threshold value is
configurable by the
user in a text file. | | |
| SRS.003
Disable system
during alert | Software shall use
relay hardware to
disable system from
scanning when alert
occurs | GE Light Speed 32;
Siemens Sensation 16;
Philips Brilliance 64;
Toshiba Aquilion 64; | Software used relay
hardware to disable
system from
scanning when alert
occurred. | PASS | |
| SRS.004
Record and
Report | Software shall record
and report CTDI and
exam information. | GE Light Speed 32;
Siemens Sensation 16;
Philips Brilliance 64;
Toshiba Aquilion 64; | Software recorded
and reported CTDI
and exam
information. | PASS | |

Table -2: Z-DOSE29 system level verification and validation summary

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9

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1. Safety and Effectiveness:
  Z-DOSE29 CT Dose Check system has similar indications for use as predicate device. The main difference is that the predicate devices employ either same CT host computer or a separate computer, that receive video signal from CT host screen for notifications, while Z-DOSE29 uses a remote computer on the same LAN as CT host computer for notifications and alerts. Risk analysis was performed to include design requirements and mitigations which prevent all known possible interferences in the normal operation of the host CT. Performance testing, along with verification and validation activities demonstrate that Z-DOSE29 is as safe and effective as predicate device.
1. Conclusion:
  Z-DOSE29 is a CT Dose Check system which has similar indications for use as the predicate devices. Performance testing, verification and validation demonstrate that Z-DOSE29 is as safe and effective as the predicate devices.