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.

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study details for the Z-DOSE29 device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the "Expected outcome" column, and the reported device performance is from the "Observed outcome" column in Table 2: Z-DOSE29 system level verification and validation summary.

Requirement ID	Acceptance Criteria (Expected Outcome)	Reported Device Performance (Observed Outcome)	Test Result
SRS.001	The software captures the CTDI value for the specified exam type (Adult Head, Adult Body, Pediatric Head, Pediatric Body, Perfusion) and compares it to AAPM Dose Check Guidelines suggested threshold value (Default Value). If the value exceeds the threshold, the software notifies the user by displaying a dialogue box. The dialogue box contains both captured CTDI value and the applied threshold value. The threshold value is configurable by the user in a text file. (This is repeated for each exam type).	The software captured the CTDI value for the specified exam type (Adult Head, Adult Body, Pediatric Head, Pediatric Body, 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 and the applied threshold value. The threshold value is configurable by the user in a text file. (This is repeated for each exam type).	PASS
SRS.002	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 box. The dialogue box contains both accumulated CTDI value and the applied threshold value. The threshold value is configurable by the user in a text file.	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 user by displaying a dialogue box. The dialogue box contained both accumulated CTDI value and the applied threshold value. The threshold value is configurable by the user in a text file.	PASS
SRS.003	Software shall use relay hardware to disable system from scanning when an alert occurs.	Software used relay hardware to disable system from scanning when alert occurred.	PASS
SRS.004	Software shall record and report CTDI and exam information.	Software recorded and reported CTDI and exam information.	PASS

2. Sample Size Used for the Test Set and Data Provenance

Test Set (for CTDI extraction accuracy): Over 2400 image data sets were used to test the Off-the-Shelf (OTS) software component responsible for extracting CTDI information.
Test Set (for system-level SRS requirements): The system-level verification and validation (Table 2) were performed on 4 different CT scanners from different manufacturers (GE Light Speed 32, Siemens Sensation 16, Philips Brilliance 64, Toshiba Aquilion 64). Lower-level requirements were verified on 9 different systems.
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It refers to "image data sets" for OTS testing and mentions specific CT scanner models from various manufacturers, suggesting a diverse, though undefined, source for testing the system.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not explicitly state the number of experts used or their specific qualifications for establishing ground truth for the test set. However, the ground truth for dose thresholds is stated to be based on "AAPM Dose Check Guidelines suggested threshold value (Default Value)." The AAPM (American Association of Physicists in Medicine) is a professional organization, implying expert consensus in the guidelines used, but not individual experts for this specific study.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set. The performance testing appears to be a direct comparison of the device's output against predefined guidelines or system requirements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The device, Z-DOSE29, is a "Dose Check system" that automates dose monitoring and alerts. It does not involve human readers interpreting images, but rather the device extracting CTDI values and comparing them to thresholds. Therefore, a study to measure human reader improvement with or without AI assistance is not applicable to this device's function.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance assessment was done. The entire performance testing described (SRS.001 to SRS.004) focuses on the software's ability to automatically capture, compare, alert, disable scanning, record, and report CTDI values based on predefined guidelines. The only human intervention mentioned is the ability for the CT operator to manually input CTDI values if the software misreads them and to input a password to re-enable scanning after an alert. The core functionality and its evaluation are standalone. The "OTS" software for CTDI extraction was tested separately for its accuracy (99%).

7. The Type of Ground Truth Used

The ground truth used for the dose notification and alert features (SRS.001 and SRS.002) is based on AAPM Dose Check Guidelines suggested threshold values. For requirements SRS.003 (disabling system) and SRS.004 (record and report), the ground truth is against the System Requirement Specifications (SRS) themselves, observing if the device performs as expected.

8. The Sample Size for the Training Set

The document mentions that the OTS software was tested using "more than 2400 image data sets." However, this refers to testing the OTS component, not training the Z-DOSE29 system itself. The document does not specify a separate training set size for the Z-DOSE29 software or any machine learning components within it (other than the OTS which it utilizes). Given the description of the device's function (extracting CTDI values from a screen via optical character recognition (OCR) and comparing them to static thresholds), it is likely more rule-based than machine learning dependent, potentially reducing the need for a traditional "training set" for the core logic, beyond perhaps any underlying OCR model.

9. How the Ground Truth for the Training Set Was Established

As no specific training set for the Z-DOSE29 software (excluding the OTS component it uses) is mentioned, the method for establishing its ground truth is also not detailed. For the OTS component's accuracy in CTDI extraction, its ground truth would likely involve manually verified CTDI values from those 2400+ image data sets.

Summary

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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-

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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

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Indications for Use

510(k) Number (if known) K170273

Device Name Z-DOSE29

Indications for Use (Describe)

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

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

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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	Tradename/model	510(k)Number	RegulationNumber	Productcode
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).

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

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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
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		Systems
Characteristics	Z-DOSE29	Syngo® VA48	SafeCT-29
Indications for Use	Z-DOSE29 DoseCheck system isintended to providedose check featuresto ComputedTomographysystems. Z-DOSE29software extractsCTDI values fromCT host computer'sscreen, compares itto predefinedthresholds, andsends notificationand alert messagesto the CT scannerdisplay monitorprior to scanning.	The SiemensSOMATOM DefinitionAS/ AS+ (Project P46)systems are intendedto produce cross-sectional images of thebody by computerreconstruction of x-raytransmission datafrom either the sameaxial plane taken atdifferent angles orspiral planes* taken atdifferent angles.(*spiral planes: theaxial planes resultedfrom the continuousrotation of detectorsand x-ray tube, andthe simultaneoustranslation of thepatient.)	The SafeCT-29 isintended for providingComputed TomographyDose Check feature toComputed TomographyX-ray systems.The SafeCT-29 isspecifically indicatedfor providing theComputed TomographyDose Check featurewhich notifies andalerts the CT equipmentoperators, prior to ascan, if the estimateddose index is above thepredefined thresholds,for CT scanners notequipped with thisfunctionality. Thedevice is indicated foruse by professionalpersonnel.
Data Inputs	Z-DOSE29 is asoftware basedsolution to extractCTDI informationfrom CT computer'sscreen through a	Host CT Digital Datadirectly interfaced bythe device software.	The SafeCT-29 uses itsown input separatehardware: The device isinterfaced to the CTscreen via a videosplitter that provides acopy of the CT screen in
Characteristics	Z-DOSE29	Syngo® VA48	SafeCT-29
	local area network(LAN) connection.		real-time. The CTscreen data is capturedby grabbing anddigitizing the videosignal. The captureddata is interpreted byOCR software.
Scan Controls	Software andhardware	Software	Software & hardware
Dose Notificationfor individualseries	Designed toperform the "DoseNotification"feature of NEMAXR-25	Designed to performthe "DoseNotification" featureof NEMA XR-25	Unknown
Dose Alert foraccumulatedCTDI	Designed toperform the "DoseAlert" feature ofNEMA XR-25	Designed to performthe "Dose Alert"feature of NEMA XR-25	The software extractsaccumulated CTDIvolper Z axis location fromthe CT screen wheneversuch information isdisplayed by thescanner. For scannersthat do not presentsuch information, theaccumulated CTDIvol iscalculated by theSafeCT-29 software.The calculation followsthe AAPM guidelinesand assumes "worstcase scenario" (i.e.calculated CTDIvol maybe higher than theactual value) in order toprevent over-the-limitscans. The SafeCT-29assumes that each z-axis position gets thedisplayed maximumCTDIvol value, andcalculates theaccumulated CTDIvolaccordingly.
Display	Host CT Screen	Host CT Screen	The SafeCT-29 has itsown external displaymonitor as a separatehardware. SafeCT-29.
Characteristics	Z-DOSE29	Syngo® VA48	SafeCT-29
			generates an audioalert to ensure the useris aware of notificationsand warnings displayedon the SafeCT-29display monitor.
Man machineinterface	Host CT keyboard &mouse	Host CT keyboard &mouse	SafeCT-29 owndedicated keyboard &mouse
Record dataoutput	Data is saved in alocal database,which can beaccessed byauthorized usersvia a web browser.Data can also beexported to excelfiles.	Not known	Data is saved in theDevice's internalmemoryand can be exportedwith a USB memorystick
Processorhardware	Off-the-shelfcomputer	Host CT Processor	Dedicated Off-the-shelfprocessor and controls

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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

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"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 fortesting	Observed outcome	Testresult
SRS.001Notificationduring AdultHead exam	The software capturesthe CTDI value forAdult Head andcompares it to AAPMDose CheckGuidelines suggestedthreshold value(Default Value). If thevalue exceeds thethreshold value, thesoftware notifies theuser by displaying adialogue box. Thedialogue box containsboth captured CTDIvalue as well as thethreshold valueapplied. The thresholdvalue is configurableby the user in a textfile.	GE Light Speed 32;Siemens Sensation 16;Philips Brilliance 64;Toshiba Aquilion 64;	The softwarecaptured the CTDIvalue for AdultHead and comparedit to AAPM DoseCheck Guidelinessuggested thresholdvalue (DefaultValue). If the valueexceeded thethreshold value, thesoftware notified theuser by displaying adialogue box. Thedialogue boxcontained bothcaptured CTDIvalue as well as thethreshold valueapplied. Thethreshold value isconfigurable by theuser in a text file.	PASS
SRS.001Notificationduring AdultBody exam	The software capturesthe CTDI value forAdult Body andcompares it to AAPMDose CheckGuidelines suggestedthreshold value(Default Value). If thevalue exceeds thethreshold value, thesoftware notifies theuser by displaying adialogue box. Thedialogue box containsboth captured CTDIvalue as well as thethreshold value	GE Light Speed 32;Siemens Sensation 16;Philips Brilliance 64;Toshiba Aquilion 64;	The softwarecaptured the CTDIvalue for AdultBody and comparedit to AAPM DoseCheck Guidelinessuggested thresholdvalue (DefaultValue). If the valueexceeded thethreshold value, thesoftware notified theuser by displaying adialogue box. Thedialogue boxcontained bothcaptured CTDIvalue as well as thethreshold value	PASS
Requirement	Expected outcome	Scanners used for testing	Observed outcome	Test result
	applied. The thresholdvalue is configurableby the user in a textfile.		value as well as thethreshold valueapplied. Thethreshold value isconfigurable by theuser in a text file.
SRS.001NotificationduringPediatric Headexam	The software capturesthe CTDI value forPediatric Head andcompares it to AAPMDose CheckGuidelines suggestedthreshold value(Default Value). If thevalue exceeds thethreshold value, thesoftware notifies theuser by displaying adialogue box. Thedialogue box containsboth captured CTDIvalue as well as thethreshold valueapplied. The thresholdvalue is configurableby the user in a textfile.	GE Light Speed 32;Siemens Sensation 16;Philips Brilliance 64;Toshiba Aquilion 64;	The softwarecaptured the CTDIvalue for PediatricHead and comparedit to AAPM DoseCheck Guidelinessuggested thresholdvalue (DefaultValue). If the valueexceeded thethreshold value, thesoftware notified theuser by displaying adialogue box. Thedialogue boxcontained bothcaptured CTDIvalue as well as thethreshold valueapplied. Thethreshold value isconfigurable by theuser in a text file.	PASS
	SRS.001NotificationduringPediatric Bodyexam	The software capturesthe CTDI value forPediatric Body andcompares it to AAPMDose CheckGuidelines suggestedthreshold value(Default Value). If thevalue exceeds thethreshold value, thesoftware notifies theuser by displaying adialogue box. Thedialogue box containsboth captured CTDIvalue as well as the	GE Light Speed 32;Siemens Sensation 16;Philips Brilliance 64;Toshiba Aquilion 64;	The softwarecaptured the CTDIvalue for PediatricBody and comparedit to AAPM DoseCheck Guidelinessuggested thresholdvalue (DefaultValue). If the valueexceeded thethreshold value, thesoftware notified theuser by displaying adialogue box. Thedialogue boxcontained both
		threshold value		captured CTDI
	Requirement	Expected outcome	Scanners used for testing	Observed outcome	Test result
	SRS.001NotificationduringPerfusionexam	threshold valueapplied. The thresholdvalue is configurableby the user in a textfile.The software capturesthe CTDI value forPerfusion andcompares it to AAPMDose CheckGuidelines suggestedthreshold value(Default Value). If thevalue exceeds thethreshold value, thesoftware notifies theuser by displaying adialogue box. Thedialogue box containsboth captured CTDIvalue as well as thethreshold valueapplied. The thresholdvalue is configurableby the user in a textfile.	GE Light Speed 32;Siemens Sensation 16;Philips Brilliance 64;Toshiba Aquilion 64;	captured CTDIvalue as well as thethreshold valueapplied. Thethreshold value isconfigurable by theuser in a text file.The softwarecaptured the CTDIvalue for Perfusionand compared it toAAPM Dose CheckGuidelinessuggested thresholdvalue (DefaultValue). If the valueexceeded thethreshold value, thesoftware notified theuser by displaying adialogue box. Thedialogue boxcontained bothcaptured CTDIvalue as well as thethreshold valueapplied. Thethreshold value isconfigurable by theuser in a text file.
SRS.002Alert if totalCTDI exceedsthreshold	The softwarecalculates total CTDIvalue from each seriesand compares theaccumulated value toAAPM Dose CheckGuidelines suggestedthreshold value(Default Value). If theaccumulated valueexceeds the thresholdvalue, the softwarealerts the user bydisplaying a dialogue	GE Light Speed 32;Siemens Sensation 16;Philips Brilliance 64;Toshiba Aquilion 64;	The softwarecalculated totalCTDI value fromeach series andcompared theaccumulated valueto AAPM DoseCheck Guidelinessuggested thresholdvalue (DefaultValue). If theaccumulated valueexceeded thethreshold value, thesoftware alerted the	PASS
Requirement	Expected outcome	Scanners used fortesting	Observed outcome	Testresult

	contains bothaccumulated CTDIvalue as well as thethreshold valueapplied. The thresholdvalue is configurableby the user in a textfile.		user by displaying adialogue box. Thedialogue boxcontained bothaccumulated CTDIvalue as well as thethreshold valueapplied. Thethreshold value isconfigurable by theuser in a text file.
SRS.003Disable systemduring alert	Software shall userelay hardware todisable system fromscanning when alertoccurs	GE Light Speed 32;Siemens Sensation 16;Philips Brilliance 64;Toshiba Aquilion 64;	Software used relayhardware to disablesystem fromscanning when alertoccurred.	PASS
SRS.004Record andReport	Software shall recordand report CTDI andexam information.	GE Light Speed 32;Siemens Sensation 16;Philips Brilliance 64;Toshiba Aquilion 64;	Software recordedand reported CTDIand examinformation.	PASS

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

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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.

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.