(113 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not describe any features or performance metrics indicative of AI/ML.
No
The device is a whole body CT scanner, which is an imaging device used for diagnosis, not therapy. Its intended use is to acquire and display cross-sectional volumes.
Yes
The device is a whole body CT scanner that acquires and displays cross-sectional volumes of the body and whole organs. This data is used by physicians to perform specialized studies, which fall under diagnostic purposes.
No
The device description explicitly states it is a "whole body CT scanner" and lists hardware components like a gantry, patient couch, and peripheral cabinets. While it includes software, it is an integral part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description: The description clearly states the device is a "whole body CT scanner" that "acquires and displays cross sectional volumes of the whole body." This is an imaging device that works externally to the body, not by analyzing samples taken from the body.
- Intended Use: The intended use describes imaging the whole body and organs, not performing tests on biological samples.
Therefore, the Aquilion ONE Vision TSX-301C/1 and TSX-301C/Z, v6.00 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, with the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, pancreas, etc.
The Aquilion ONE has the capability to provide volume sets of the entire organ. These volume sets can be used to perform specialized studies, using indicated software/hardware, of the whole organ by a trained and qualified physician.
Product codes
JAK
Device Description
The Aquillion ONE Vision TSX-301C/1 and TSX-301C/Z, v6.00 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display. These systems are based upon the technology and materials of previously marketed Toshiba CT systems.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography
Anatomical Site
whole body, to include the head. Whole organs include but are not limited to brain, heart, pancreas, etc.
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)
This Special 510(k) submission includes summary tables detailing the risk analysis and verification/validation testing conducted through bench testing which demonstrates that the requirements for the modifications made to the system have been met.
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.
Additionally, testing of the modified system was conducted in accordance with the applicable standards published by the International Electrotechnical Commission (IEC) for Medical Devices and CT Systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K1322222
Page 1 of 3
TOSHIBA AMERICA MEDICAL BYBTEMS, INC.
2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 730-5000
510(k) SUMMARY
-
- SUBMITTER'S NAME: Toshiba America Medical Systems, Inc.
-
- ADDRESS: 2441 Michelle Drive Tustin, CA 92780-2068
-
- ESTABLISHMENT REGISTRATION: 2020563
NOV 07 2013
4. CONTACT PERSON: Paul Biggins
Director, Regulatory Affairs (714) 730-5000
-
- Date Prepared: July 16, 2013
-
- TRADE NAME(S): Aquilion ONE Vision, TSX-301C/1 and 301C/2, v6.00
-
- COMMON NAME: System, X-ray, Computed Tomography
-
- DEVICE CLASSIFICATION: Class II (per 21 CFR 892.1750)
9. PRODUCT CODE / DESCRIPTION:
JAK - System, Computed Tomography
10. PERFORMANCE STANDARD:
This device conforms to applicable Performance Standards for lonizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020]
11. PREDICATE DEVICE:
| Product | Marketed by | 510(k) Number | Clearance Date |
|---|---|---|---|
| Aquilion ONE Vision, | |||
| TSX-301C/1, v4:90 | Toshiba America | ||
| Medical Systems | K122109 | September 21, 2012 |
1
12. REASON FOR SUBMISSION:
Modification of a cleared device
13. DEVICE DESCRIPTION:
The Aquillion ONE Vision TSX-301C/1 and TSX-301C/Z, v6.00 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display. These systems are based upon the technology and materials of previously marketed Toshiba CT systems.
14. SUMMARY OF INTENDED USES:
This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head, with the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, pancreas, etc.
The Aquilion ONE has the capability to provide volume sets of the entire organ. These volume sets can be used to perform specialized studies, using indicated software/hardware, of the whole organ by a trained and qualified physician.
15. SUBSTANTIAL EQUIVALENCE:
This device is substantially equivalent to the Aquilion ONE Vision, TSX-301C/1, v4.90, K122109, marketed by Toshiba America Medical Systems. The Aquilion ONE Vision TSX-301C/1 and TSX-301C/2, v6.00, incorporates modifications to the cleared device which include an operating system change, image quality improvements, dose reduction availability in real time scanning and addition of previously 510(k) cleared post processing software. The indications for use, method of operation including the imaging chain, base software and manufacturing process remain unchanged from the cleared device.
A complete comparison table is included in this submission. See below for a brief summary of changes from Aquilion ONE Vision, TSX-301C/1, v4.90:
| Item | Aquilion ONE Vision
TSX-301C/1 and TSX-301C/2, v6.00 | Aquilion ONE Vision
TSX-301C/1, v4.90 |
|----------------------|---------------------------------------------------------|------------------------------------------|
| Operating System | Windows 7 | Windows XP |
| Subtraction Protocol | Optional | N/A |
| Image Quality | Metal Artifact Reduction | Beam Hardening Correction |
| | Improved Cone Beam Artifact Reduction | Cone Beam Artifact Reduction |
| | Improved MIP Image | MIP Image |
| Dose Reduction | AIDR available during CT Fluoroscopy | N/A |
| Lung Volume Analysis | Optional
(Previously cleared under K113715) | N/A |
2
K132222
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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 IEC60601-1, IEC60601-1-1, IEC60601-1-2, IEC60601-1-3, IEC60601-1-4, IEC60601-1-6, IEC60601-1-8, IEC60601-2-28, IEC60601-2-32, IEC60601-2-44, IEC60825-1, IEC62304, IEC62366, NEMA PS 3.1-3.18, NEMA XR-25 and NEMA XR-26. Additionally, this device complies with all applicable requirements of the radiation safety performance standards, as outlined in 21 CFR §1010 and §1020.
17. TESTING
This Special 510(k) submission includes summary tables detailing the risk analysis and verification/validation testing conducted through bench testing which demonstrates that the requirements for the modifications made to the system have been met.
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.
Additionally, testing of the modified system was conducted in accordance with the applicable standards published by the International Electrotechnical Commission (IEC) for Medical Devices and CT Systems.
18. CONCLUSION
The modifications incorporated into the Aquilion ONE Vision TSX-301C/1 and TSX-301C/2, v6.00 do not change the indications for use or the intended use of the device. Based upon bench testing, successful completion of software validation, application of risk management and design controls, it is concluded that the subject device is safe and effective for its intended use.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines and two wavy lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 7, 2013
Toshiba Medical Systems Corporation % Mr. Paul Biggins Director, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K132222
Trade/Device Name: Aquilion ONE Vision, TSX-301C/1 and 301C/2, v6.00 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: October 30, 2013 Received: October 31, 2013
Dear Mr. Biggins:
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 10 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-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.
4
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/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 Small Manufacturers, International and Consumer Assistance 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 yours,
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
for
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name:
Aquilion ONE Vision, TSX-301C/1 and 301C/2, v6.00
Indications for Use:
This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head, with the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, pancreas, etc.
The Aquilion ONE has the capability to provide volume sets of the entire organ. These volume sets can be used to perform specialized studies, using indicated software/hardware, of the whole organ by a trained and qualified physician.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Smh.7)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
K132222 510(k)_
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