(170 days)
Not Found
No
The summary does not mention AI, ML, deep learning, or any related terms, and the performance studies focus on image quality metrics and substantial equivalence to a predicate device, which is typical for traditional CT scanners.
No.
The device is a CT scanner indicated for acquiring and displaying cross-sectional images for diagnostic purposes, not for treating any condition or disease.
Yes
The device is described as capturing "cross sectional volume data sets" and producing "images of diagnostic quality," explicitly stating its purpose is to acquire and display volumes for "specialized studies" by a "trained and qualified physician." This aligns with the function of a diagnostic device.
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.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a whole body CT scanner used to "acquire and display cross-sectional volumes of the whole body." This is an imaging device that works directly on the patient's body, not on specimens taken from the body.
- Intended Use: The intended use is to acquire and display images of the whole body for diagnostic purposes, which is consistent with an imaging device, not an IVD.
The information provided describes a medical imaging device used for diagnostic purposes through direct imaging of the patient, not through the analysis of in vitro specimens.
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 has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
The Aquilion LB Triton, TSX-201A/2, v4.91 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography
Anatomical Site
whole body, to include the head
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 comparison data using brain, chest, abdomen and pelvis anthropomorphic phantoms, utilizing clinical scan conditions and reconstruction parameters, demonstrated that the subject device produces substantially equivalent images of representative structures as compared to the predicate device, Aquilion LB CT Scanner TSX-201A.
An image quality metrics study utilizing phantoms validated that the subject device is substantially equivalent to the predicate device (Aquilion LB CT Scanner TSX-201A) with regard to spatial resolution, CT number and contrast-to-noise ratio, uniformity, noise properties and low contrast resolution.
Additionally, representative diagnostic images including brain, chest, abdomen and peripheral exams were obtained using the subject device which demonstrates that the device produces images of diagnostic quality and; therefore, performs as intended.
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 with satisfactory results.
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.
Not Found
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
K123500
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SYSTEMS, INC. TOSHIBA AMERICA MEDICA 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
4. CONTACT PERSON: Paul Biggins Director, Regulatory Affairs (714) 730-5000
-
- Date Prepared: November 8, 2012 (Updated: March 22, 2013)
6. TRADE NAME(S): Aquilion LB Triton, TSX-201A/2, v4.91
-
- COMMON NAME: . System, X-ray, Computed Tomography
-
- DEVICE CLASSIFICATION: Class II (per 21 CFR 892.1750)
-
- 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 LB CT Scanner TSX-201A | Toshiba America | ||
| Medical Systems | K050458 | March 10, 2005 | |
| Aquilion ONE TSX-301A/2, w/4.74ER | |||
| (Dose Reduction Technology) | Toshiba America | ||
| Medical Systems | K113466 | April 10, 2012 |
2 2013 MAY
1
K123500
Page 2 of 3
12. REASON FOR SUBMISSION:
Modification of a cleared device
13. DEVICE DESCRIPTION:
The Aquilion LB Triton, TSX-201A/2, v4.91 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.
14. SUMMARY OF INTENDED USES:
This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head.
The Aquilion has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.
15. SUBSTANTIAL EQUIVALENCE:
This device is substantially equivalent to the Aquilion LB CT Scanner, TSX-201A, K050458, marketed by Toshiba America Medical Systems. The Aquillion LB Triton, TSX-201A/2, v4.91, includes modifications to the cleared device which improves image reconstruction speed and includes the addition of optional software features. There is no change to the imaging chain in the gantry. The method of operation, base software and manufacturing process remain unchanged from the cleared device.
Additionally, this device is substantially equivalent to the Aquilion ONE TSX-301A/2, w/4.74ER, K113466, in that it includes the previously cleared dose reduction technology, AIDR 3D.
| Item | Aquilion LB Triton
TSX-201A/2, v4.91 | Aquilion LB CT
Scanner TSX-201A
(K050458) | Aquilion ONE TSX-
301A/2, w/4.74ER
(K113466) |
|-----------------------------------------|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Image reconstruction
(maximum speed) | 22 images per second | 12 images per second | 30 images per second |
| X-ray Generator
Output Power | 72kW Maximum | 60kW Maximum | 70kW Maximum |
| Dose Reduction | SureExposure 3D | Real EC | SureExposure 3D |
| Noise Reduction
Processing | QDS
AIDR 3D | N/A | QDS
AIDR 3D |
| Console | • 2.53 GHz CPU Clock
Frequency
• 12 GB or more CPU
Memory
• DVD Drive | • 2 GHz CPU Clock
Frequency
• 2 GB or more CPU
Memory
• CD Drive | • 3.0 GHz CPU Clock
Frequency
• 8 GB or more CPU
Memory
• DVD Drive |
Summary of Changes:
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2
K123500
page 3 of 3
-
- Increased image reconstruction speed
-
- High voltage generator is increased
- ని. Noise reduction processing software is now a standard feature
-
- The computer console has been upgraded, which includes a faster CPU, additional CPU memory, a DVD Drive.
- ട. An optional Display Console Kit is now available.
-
- Previously cleared software options are being added
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, IEC60601-1-1, IEC60601-1-2, IEC60601-1-3, IEC60601-1-4, IEC60601-1-6, IEC60601-1-8, IEC60601-1-9, IEC60601-2-28. IEC60601-2-32. IEC60601-2-44. IEC60825-1. IEC62304. IEC62366. NEMA PS 3.1-3.18 and NEMA XR-25.
Additionally, this device complies with all applicable requirements of the radiation safety performance standards, as outlined in 21 CFR §1010 and §1020.
17. TESTING
There is no change to the imaging chain in the gantry (i.e. geometry, detector/DAS, tube, beam limiting device). Image comparison data using brain, chest, abdomen and pelvis anthropomorphic phantoms, utilizing clinical scan conditions and reconstruction parameters, demonstrated that the subject device produces substantially equivalent images of representative structures as compared to the predicate device, Aquilion LB CT Scanner TSX-201A.
An image quality metrics study utilizing phantoms validated that the subject device is substantially equivalent to the predicate device (Aquilion LB CT Scanner TSX-201A) with regard to spatial resolution, CT number and contrast-to-noise ratio, uniformity, noise properties and low contrast resolution.
Additionally, representative diagnostic images including brain, chest, abdomen and peripheral exams were obtained using the subject device which demonstrates that the device produces images of diagnostic quality and; therefore, performs as intended.
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 with satisfactory results.
18. CONCLUSION
The modifications incorporated into the Aquilion LB Triton, TSX-201A/2, v4.91 do not change the indications for use or the intended use of the device. Based upon this information, conformance to standards, application of design controls and the performance data presented in this submission, Toshiba America Medical Systems, believes that the Aquilion LB Triton, TSX-201A/2, v4.91, is substantially equivalent in safety and effectiveness to the predicate devices.
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" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing protection and care.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 2. 2013
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. % Mr. Paul Biggins Director, Regulatory Affairs 2441 Michelle Drive TUSTIN CA 92780
Re: K123500
Trade/Device Name: Aquilion LB Triton, TSX-201A/2, v4.91 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 22, 2013 Received: March 28, 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 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-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
Page 2 - Mr. Biggins
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/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,
Sm-7)
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K123500
Device Name: Aquilion LB Triton, TSX-201A/2, v4.91
Indications for Use:
This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head.
The Aquilion has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 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)
Sm. 7)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K123500 510(k)
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