(107 days)
No
The summary describes an iterative reconstruction algorithm (FIRST 3.0) which is a common image processing technique in CT, but it does not mention or imply the use of AI or ML. The performance studies focus on traditional image quality metrics and phantom studies, not AI/ML specific evaluations.
No
This device is an imaging device used for diagnosis, not for treating a condition or disease.
Yes
The device is described as a "multi-slice helical CT scanner" that acquires and displays "cross-sectional volumes of the whole body". This imaging modality is used by "a trained and qualified physician" to "perform specialized studies". The performance studies also include evaluation of "diagnostic images, reviewed by an American Board Certified Radiologist", which "demonstrates that the device produces images of diagnostic quality". These all indicate that the device is intended for diagnostic purposes.
No
The device description explicitly states it is a "whole body multi-slice helical CT scanner, consisting of a gantry, couch and a console used for data processing and display." This indicates it includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes acquiring and displaying cross-sectional volumes of the body for specialized studies using indicated software/hardware. This is a description of a medical imaging device used for diagnosis based on anatomical information, not on the analysis of biological samples (which is the core of IVD).
- Device Description: The device is described as a CT scanner, which is a medical imaging modality.
- Performance Studies: The performance studies focus on image quality metrics (CT number accuracy, contrast-to noise ratio, uniformity, spatial resolution, low contrast detectability, etc.) and dose reduction. These are typical performance evaluations for medical imaging devices, not IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on biochemical or molecular markers.
Therefore, the Aquilion Precision CT scanner is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Precision has the capability to provide volume sets. These volume sets can be used to perform specialized studies, usinq indicated software/hardware, by a trained and qualified physician.
FIRST 3.0 is an iterative reconstruction algorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis, chest, cardiac, extremities and head applications.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 is an ultra-high resolution whole body multi-slice helical CT scanner, consisting of a gantry, couch and a console used for data processing and display. Aquilion Precision incorporates a 160-row, 0.25 mm detector, a 5.7-MHU large-capacity tube, and 0.35 s scanning, enabling wide-range scanning with short scan times to capture cross sectional volume data sets used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician. In addition, the subject device incorporates the latest iterative reconstruction technology, FIRST 3.0, intended to reduce exposure dose while maintaining and/or improving image quality.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography x-ray system
Anatomical Site
Whole body, to include the head, abdomen, pelvis, chest, cardiac, extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained and qualified physician
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)
Image Quality Evaluation
CT image quality metrics were performed, utilizing phantoms, to assess CT number accuracy, contrast-to noise ratio, uniformity, slice sensitivity profile, modulation transfer function, low contrast detectability, standard deviation of noise and noise power spectra. The Aquilion Precision in NR mode is substantially equivalent to the predicate device. The HR and SHR modes yield improved high contrast spatial resolution with some tradeoff in noise and LCD relative to NR mode. The FIRST algorithm demonstrates equivalent or improved image quality relative to FBP for all modes. A high contrast spatial resolution claim of "up to 46.1 lp/cm based upon the 2% of the MTF of images of a wire test object acquired in HR mode, under the axial scan mode and reconstructed with FC90" is supported. As demonstrated by the performance of FIRST at reduced mA values for standard deviation, MTF, and visual LCD as compared to FBP at higher mA values a qualitative claim of Dose Reduction with FIRST is supported.
Confirmation of Spatial Resolution
The spatial resolution claim was confirmed by measuring the MTF results of seven Aquilion Precision systems. It was determined that a high contrast spatial resolution claim of up to 49.5 lp/cm, based upon the 2% of the MTF of images of a wire test object acquired in HR mode and reconstructed with FC90, is supported.
Low Contrast Detectability Equivalence in Normal Resolution vs High Resolution Modes
A study was conducted utilizing the Head and Body MITA-FDA LCD phantoms to establish a baseline LCD value (AUC) in Normal Resolution (NR) mode using a protocol based on Toshiba's standard adult abdomen protocol and standard adult head protocol, with a fixed technique at a clinically realistic CTDI, and reconstructed with Filtered Backprojection (FBP), AIDR Enhanced, and FIRST. Results of the study demonstrated that scanning in high resolution mode (HR) and in super high resolution mode (SHR) may result in equivalent or a modest increase in Xray dose as compared to scanning in normal resolution mode (NR).
Size Discrimination Performance
A model observer study was conducted comparing detectability of a 0.5 mm change in object radius in Normal Resolution vs High Resolution mode utilizing the Catphan 10HU contrast rods, 4-9mm in diameter, which demonstrated a 50% improvement in size discrimination with High Resolution mode compared to Normal Resolution mode at the same dose.
Alternatives to clinical images of cardiac and extremities using cardiac stent and cadaver
A study was conducted to provide cadaver and cardiac stent images for certain anatomical regions in lieu of sample clinical images acquired in NR and HR mode since these examples were not available. This study demonstrated that NR mode and predicate device images were substantially equivalent and that the images acquired in HR and SHR modes showed improved spatial resolution as compared to images acquired in NR mode.
Representative diagnostic images, reviewed by an American Board Certified Radiologist, including head, chest, abdomen/pelvis, extremity and cardiac exams were also obtained using the subject device which demonstrates that the device produces images of diagnostic quality and; therefore, performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health and Human Services logo. The logo on the right is the Food and Drug Administration logo. The FDA logo is in blue and contains the words "FDA U.S. FOOD & DRUG ADMINISTRATION".
Toshiba Medical Systems Corporation % Orlando Tadeo, Jr. Manager, Regulatory Affairs Toshiba America Medical Systems, Inc 2441 Michelle Drive TUSTIN CA 92780
February 23, 2018
Re: K173468
Trade/Device Name: Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: January 10, 2018 Received: January 11, 2018
Dear Mr. Tadeo:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert 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)
K173468
Device Name
Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0
Indications for Use (Describe)
This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Precision has the capability to provide volume sets. These volume sets can be used to perform specialized studies, usinq indicated software/hardware, by a trained and qualified physician.
FIRST 3.0 is an iterative reconstruction algorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis, chest, cardiac, extremities and head applications.
Type of Use (Select one or both, as applicable)
ك Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) SUMMARY
-
- SUBMITTER'S NAME: Toshiba Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
- OFFICIAL CORRESPONDENT: 2. Naofumi Watanabe Senior Manager, Regulatory Affairs and Vigilance
-
- ESTABLISHMENT REGISTRATION: 9614698
4. CONTACT PERSON:
Orlando Tadeo, Jr. Manager, Regulatory Affairs Toshiba America Medical Systems, Inc 2441 Michelle Drive Tustin, CA 92780 (714) 669-7459
ട. Date Prepared:
February 20, 2018
6. TRADE NAME(S):
Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0
7. COMMON NAME:
System, X-ray, Computed Tomography
-
- DEVICE CLASSIFICATION (Regulatory Class, CFR Reference, Name): Class II (per 21 CFR 892.1750, Computed Tomography X-ray System)
9. PRODUCT CODE / DESCRIPTION:
JAK / Computed Tomography X-Ray System
10. PERFORMANCE STANDARD:
This device conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020]
Image /page/3/Picture/20 description: The image shows the Canon logo in red, with the words "CANON GROUP" in black below it. The words "Page 1 of 6" are located in the bottom left corner of the image. The logo and text are crisp and clear against a white background.
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11. PREDICATE DEVICE:
| Product | Marketed | Regulation Regulation | Product Code | 510(k) | Clearance | |
|---|---|---|---|---|---|---|
| by | Number | Name | Number | Date | ||
| Aquilion PRIME, | ||||||
| TSX-303A/A, /B and /F, | ||||||
| v6.00 | ||||||
| (Primary Predicate | ||||||
| Device) | Toshiba | |||||
| America | ||||||
| Medical | ||||||
| Systems | 21 CFR | |||||
| 892.1750 | Computed | |||||
| Tomography | ||||||
| X-ray System | JAK: | |||||
| System, X-ray, | ||||||
| Tomography, | ||||||
| Computed | K141741 | 11/11/2014 | ||||
| Aquilion ONE (TSX- | ||||||
| 305A/3) V8.3 with | ||||||
| FIRST 2.1 | Toshiba | |||||
| America | ||||||
| Medical | ||||||
| Systems | 21 CFR | |||||
| 892.1750 | Computed | |||||
| Tomography | ||||||
| X-ray System | JAK: | |||||
| System, X-ray, | ||||||
| Tomography, | ||||||
| Computed | K170177 | 06/30/2017 |
12. REASON FOR SUBMISSION:
New medical device
13. DEVICE DESCRIPTION:
Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 is an ultra-high resolution whole body multi-slice helical CT scanner, consisting of a gantry, couch and a console used for data processing and display. Aquilion Precision incorporates a 160-row, 0.25 mm detector, a 5.7-MHU large-capacity tube, and 0.35 s scanning, enabling wide-range scanning with short scan times to capture cross sectional volume data sets used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician. In addition, the subject device incorporates the latest iterative reconstruction technology, FIRST 3.0, intended to reduce exposure dose while maintaining and/or improving image quality.
14. INDICATIONS FOR USE:
This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head.
The Aquilion Precision has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software, by a trained and qualified physician.
FIRST 3.0 is an iterative reconstruction algorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis, chest, cardiac, extremities and head applications.
15. SUBSTANTIAL EQUIVALENCE:
The Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0, is substantially equivalent to the Aquilion PRIME, TSX-303A/A, /B and /F v6.00, which received premarket clearance under K141741 and is marketed by Toshiba America Medical Systems. The intended use of the Aquilion Precision is the same as that of the predicate device. Software applications that have already received 510(k) clearance are being implemented on the subject device. The main difference between the Aquilion Precision and the predicate device is the configuration of the detector as well as the implementation of two new acquisition modes, HR (High Resolution) and
5
SHR (Super High Resolution), in addition to the conventional, NR (Normal Resolution) mode, which provides the user with image quality improvements. The NR mode is substantially equivalent to the acquisition mode employed by the predicate device. A comparison of the technological characteristics between the subject and the predicate device is included below.
| ltem | Aquilion Precision (TSX-304A/2)
V8.6 with FIRST 3.0 | Aquilion PRIME, TSX-303A/A, /B
and /F v6.00 | |
|---------------------------------------|--------------------------------------------------------------------|------------------------------------------------|--|
| 510(k) Number | This submission | K141741 | |
| Configuration of the detector | 0.25 mm x 160 rows | 0.5 mm x 80 rows | |
| Detector | 1792 channels × 160 rows | 896 channels × 80 rows | |
| Max. scan length/rotation | 40 mm/rotation | 40 mm/rotation | |
| Acquisition Modes | NR mode: | | |
| | 0.5mm x 80 rows / 896 channels | 0.5mm x80 rows /896 channels | |
| | HR mode: | | |
| | 0.5mm x 80 rows /1792 channels | | |
| | SHR mode: | | |
| | 0.25mm x 160 rows /1792
channels | | |
| Reconstruction Matrix | NR mode: 512×512 | 512 x 512 | |
| | HR & SHR mode: 512×512, 1024×1024 | | |
| FOV (field of view) | 320/500mm in diameter | 180/240/320/400/500 mm in
diameter | |
| Wedge filter Types | Three types | Three types | |
| | Small1:FOV M | Small :FOV SS, S | |
| | Large1:FOV L | Medium :FOV M | |
| | Large2:FOV L | Large :FOV L, LL | |
| X-ray tube capacity | 5.7 MHU | 7.5 MHU | |
| Maximum tube cooling rate | 1,026 kHU/min | 1,386 kHU/min | |
| Continuous tube cooling rate | 660 kHU/min | 1,008 kHU/min | |
| Focal spots size | Small: Two types | Small: One type | |
| | Large: Four types | Large: One type | |
| CPU memory | 256 Gbyte or more | 12 Gbyte or more | |
| Image reconstruction time | Up to 80 images/s | Up to 30 images/s (0.033 s/image) | |
| (Max. speed) | (0.0125 s/image) | Option: | |
| | | Up to 60 images/s (0.017 s/image) | |
| Magnetic disk | 9.8 TB or more | 915 GB or more | |
| | Raw data: 4,000 rotations or more | Raw data: 4000 rotations | |
| | | Image data: 500,000 images | |
| Item | Aquilion Precision (TSX-304A/2)
V8.6 with FIRST 3.0 | Aquilion PRIME, TSX-303A/A, /B
and /F v6.00 | |
| 510(k) Number | This submission | K141741 | |
| BD-RE(Blu-ray Disc) | Image data: 2,000,000 images or
more (1024 x 1024 pixel images) | N/A | |
| | 25 GB
Image data:10,000 images (1024 x
1024 pixel images) | | |
| Noise reduction processing | AIDR 3D
AIDR3D Enhanced | QDS
AIDR 3D
AIDR3D Enhanced | |
| Metal artifact reduction | SEMAR(Volume, Helical)
SEMAR (ECG gated) | SEMAR(Volume, Helical)
SEMAR (ECG gated) | |
| Gantry opening size | 780 mm in diameter | 780 mm in diameter | |
| Tilt angle | $\pm$ 30° | $\pm$ 30° | |
| Patient Couch | | | |
| Vertical movement: | 2050mm | 2390mm | |
| Couch top stroke | 1750mm | 1890mm | |
| Frame slide stroke | 330mm | N/A | |
| Scan permissible range: | 2000mm | 2000mm | |
| Conventional | 1700mm | 1500mm | |
| Scan permissible range: | 1950mm | 1950mm | |
| Helical | 1650mm | 1450mm | |
| Couch-top Speed of
movement (fast) | 200mm/s | 200mm/s | |
| Vertical movement stroke | 520mm | 568mm | |
| Couch-top width | 470mm | 470mm | |
| Lowest couch height | 420mm | 332mm | |
| Max. guaranteed weight | 300kg | 300kg | |
| Footswitch | Standard | Standard | |
| Lateral movement unit | Optional | Optional | |
| Movement speed | 20mm/s | 10mm/s | |
| Lateral Stroke (right and
left) | 170mm (85mm in the lateral
direction) | 84mm (42mm in the lateral
direction) | |
| FIRST 3.0 | Optional | N/A | |
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16. SAFETY:
The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the following standards IEC60601-1, IEC60601-1-3, IEC60601-1-6, IEC60601-1-6, IEC60601-2-28, IEC60601-2-44, IEC60825-1, IEC62304, IEC62366, NEMA PS 3.1-3.18, NEMA XR-25, NEMA XR-26 and NEMA XR-29. Additionally, this device complies with all applicable requirements of the radiation safety performance standards, as outlined in 21 CFR §1010 and §1020.
17. TESTING
Risk analysis and verification/validation testing conducted through bench testing demonstrate that the established specifications for the device have been met.
Image Quality Evaluation
CT image quality metrics were performed, utilizing phantoms, to assess CT number accuracy, contrast-to noise ratio, uniformity, slice sensitivity profile, modulation transfer function, low contrast detectability, standard deviation of noise and noise power spectra. The Aquilion Precision in NR mode is substantially equivalent to the predicate device. The HR and SHR modes yield improved high contrast spatial resolution with some tradeoff in noise and LCD relative to NR mode. The FIRST algorithm demonstrates equivalent or improved image quality relative to FBP for all modes. A high contrast spatial resolution claim of "up to 46.1 lp/cm based upon the 2% of the MTF of images of a wire test object acquired in HR mode, under the axial scan mode and reconstructed with FC90" is supported. As demonstrated by the performance of FIRST at reduced mA values for standard deviation, MTF, and visual LCD as compared to FBP at higher mA values a qualitative claim of Dose Reduction with FIRST is supported.
Confirmation of Spatial Resolution
The spatial resolution claim was confirmed by measuring the MTF results of seven Aquilion Precision systems. It was determined that a high contrast spatial resolution claim of up to 49.5 lp/cm, based upon the 2% of the MTF of images of a wire test object acquired in HR mode and reconstructed with FC90, is supported.
Low Contrast Detectability Equivalence in Normal Resolution vs High Resolution Modes
A study was conducted utilizing the Head and Body MITA-FDA LCD phantoms to establish a baseline LCD value (AUC) in Normal Resolution (NR) mode using a protocol based on Toshiba's standard adult abdomen protocol and standard adult head protocol, with a fixed technique at a clinically realistic CTDI, and reconstructed with Filtered Backprojection (FBP), AIDR Enhanced, and FIRST. Results of the study demonstrated that scanning in high resolution mode (HR) and in super high resolution mode (SHR) may result in equivalent or a modest increase in Xray dose as compared to scanning in normal resolution mode (NR).
Size Discrimination Performance
A model observer study was conducted comparing detectability of a 0.5 mm change in object radius in Normal Resolution vs High Resolution mode utilizing the Catphan 10HU contrast rods, 4-9mm in diameter, which demonstrated a 50% improvement in size discrimination with High Resolution mode compared to Normal Resolution mode at the same dose.
8
Alternatives to clinical images of cardiac and extremities using cardiac stent and cadaver A study was conducted to provide cadaver and cardiac stent images for certain anatomical regions in lieu of sample clinical images acquired in NR and HR mode since these examples were not available. This study demonstrated that NR mode and predicate device images were substantially equivalent and that the images acquired in HR and SHR modes showed improved spatial resolution as compared to images acquired in NR mode.
Representative diagnostic images, reviewed by an American Board Certified Radiologist, including head, chest, abdomen/pelvis, extremity and cardiac exams were also obtained using the subject device which demonstrates that the device produces images of diagnostic quality and; therefore, performs as intended.
Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission.
Cybersecurity documentation, per the FDA cybersecurity premarket guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices " issued on October 2, 2014, is also included as part of this submission.
Additionally, testing of the subject device was conducted in accordance with the applicable standards published by the International Electrotechnical Commission (IEC) for Medical Devices and CT Systems.
18. CONCLUSION
The Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 performs in a manner similar to and is intended for the same use as the predicate device, as indicated in product labeling. Based upon this information, conformance to standards, successful completion of software validation, application of risk management and design controls and the performance data presented in this submission it is concluded that the subject device has demonstrated substantial equivalence to the predicate device and is safe and effective for its intended use.