(62 days)
TSX-301A/2 - K093891
Not Found
No
The document does not mention AI, ML, or related terms, and the description focuses on standard CT technology and image acquisition.
No.
The device is a CT scanner, which is used for diagnostic imaging (acquiring and displaying images), not for treating conditions.
Yes
The device is a whole body CT scanner that acquires and displays cross-sectional volumes of the body. This imaging data is explicitly stated to "be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician," which is characteristic of diagnostic use.
No
The device description explicitly states it is a whole body CT scanner consisting of a gantry, patient couch, and peripheral cabinets, indicating it is a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "acquire and display cross-sectional volumes of the whole body, to include the head." This describes an imaging device used to visualize internal structures of the body.
- Device Description: The device is described as a "whole body CT scanner." CT scanners are imaging devices, not devices used to examine specimens taken from the body.
- Lack of mention of in vitro testing: There is no mention of analyzing samples (blood, tissue, etc.) taken from the body. IVD devices are specifically designed for testing these types of samples.
In summary, the device is a medical imaging device used for diagnostic purposes by visualizing the internal anatomy of a patient, which is distinct from the function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This device is indicated to a acquire and display cross-sectional volumes of the whole body, to include the head.
The Aquilion RXL 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 TSX-101A/R is a whole body CT scanner. This device captures helical volumetric data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Computed Tomography (CT)
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
Testing was conducted utilizing phantoms and accepted image quality metrics. The results of this testing is contained in the user information for the device. Additional testing was conducted at numerous beta sites to provide clinical data for the validation of the software change.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was conducted utilizing phantoms and accepted image quality metrics. The results of this testing is contained in the user information for the device. Additional testing was conducted at numerous beta sites to provide clinical data for the validation of the software change.
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.
TSX-301A/2 - K093891
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.
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K.121553
Toshiba America Medical Systems, Inc. · Pre-Market Notification 510(k) TSX-301A/2 Aquilion ONE w/4.74ER Software
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510(k) - SUMMARY OF SAFETY AND EFFECTIVENESS
JUL 26 2012
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- SUBMITTER'S NAME: Toshiba America Medical Systems, Inc.
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- ADDRESS: 2441 Michelle Drive Tustin, CA. 92780-2068
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- ESTABLISHMENT REGISTRATION: 2020563
4. CONTACT PERSON: Paul Biggins
Director, Regulatory Affairs (714) 730-5000
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- TRADE NAME(S): TSX-101A/R; Aquilion RXL
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- COMMON NAME: System, X-ray, Computed, Tomography
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- DEVICE CLASSIFICATION: Class II (per 21 CFR 892,1750)
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- PRODUCT CODE / DESCRIPTION: JAK - System, Computed Tomography
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- PERFORMANCE STANDARD: 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard
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- PREDICATE DEVICE: TSX-301A/2 - K093891
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- REASON FOR SUBMISSION: Modification of a cleared device
12. DEVICE DESCRIPTION:
The TSX-101A/R is a whole body CT scanner. This device captures helical volumetric data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display.
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1011 311188 Mar. El 110
Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) TSX-301A/2 Aquilion ONE w/4.74ER Software
13. SUMMARY OF INTENDED USES:
This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head.
. I(K)
The Aquilion RXL 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.
14. SUBSTANTIAL EQUIVALENCE:
The modification to this device is to reduce radiation exposure to the patient. The modification allows for the use of an iterative reconstruction algorithm that provides the user the ability to perform scans at lower doses. The materials, hardware, method of operation, base software and manufacturing processes remain unchanged from the cleared device: TSX301A/2 (K093891).
| New feature | |
|---|---|
| Maximum number of slices | Changed from 16 to 32 |
| Application of AIDR algorithm | Not available on previous version |
| Active Collimation | Not available on previous version. |
| Improved Computational | |
| Hardware | Updated computer and associated |
| hardware from previous version. |
15. 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 standards and its collateral standards. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR §1020, that apply to this device, will be met and reported via product report.
16. SUMMARY OF TESTING:
Testing was conducted utilizing phantoms and accepted image quality metrics. The results of this testing is contained in the user information for the device. Additional testing was conducted at numerous beta sites to provide clinical data for the validation of the software change.
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Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) Market Notification 11 in 1 TSX-301A/2 Aquilion ONE w/4.74ER Software ヘッド・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
17. CONCLUSION
The additional features that are being added to the Aquilion RXL at this time do not change the indication for use or the intended use of the device. Safety and effectiveness have been verified via risk management and application of design controls to this modification.
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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming a stylized human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus. The seal is in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring. MD 20993-0002
JUL 26 2012
Toshiba Medical Systems Corporation % Mr. Paul Biggins Director Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K121553
Trade/Device Name: Aquillion RXL; TSX-101A Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: May 24, 2012 Received: May 25, 2012
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 aird 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nouncation. The FD F in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
510(k) Number (if known): _
Device Name: Aquillion RXL; TSX-101A
Indications for Use:
This device is indicated to a acquire and display cross-sectional volumes of the whole body, to include the head.
The Aquilion RXL 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 Prescription Use
(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 OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Muhal D. O'Brien
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K121553
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