(187 days)
No
The summary describes a standard CT system with dose reduction technologies, but there is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as an imaging system (CT System) used for the acquisition and display of x-ray images, with an emphasis on reducing patient dose and improving image quality. Its purpose is diagnostic imaging, not therapeutic treatment.
Yes
The device is described as a "multi-slice helical CT System" used for "Acquisition and display of axial x-ray images of the whole body." CT scans are a common diagnostic imaging modality used by healthcare professionals to visualize internal structures for the diagnosis of medical conditions.
No
The device description clearly states it is a "whole body multi-slice helical CT System, consisting of a gantry, patient couch and console," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Acquisition and display of axial x-ray images of the whole body to include the head." This describes an imaging device used to visualize internal structures of the body.
- Device Description: The description details a CT system, which is a type of medical imaging equipment that uses X-rays to create cross-sectional images of the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This device directly images the body itself, not specimens taken from it.
Therefore, the Aquilion CXL is a medical imaging device, specifically a CT scanner, and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This device is designed to produce cross-sectional images of a human body by reconstruction of x-ray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blood clots in the brain, eye trauma, soft tissue lesions in the extremities, gastro intestinal lesions, abdominal and pelvic malignancies and hepatic metastases. CT is also used to evaluate intestinal obstructions, as intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no intended uses that are not in cleared devices already found in the market place.
Acquisition and display of axial x-ray images of the whole body to include the head.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
The Aquilion CXL is a whole body multi-slice helical CT System, consisting of a gantry, patient couch and console. The system generates up to 128 slices per rotation using a selectable slice-thickness multi-row detector. Additionally, the Aquilion CXL will utilize the new dose-reduction technologies adopted from Aquilion ONE (currently under FDA review), the system substantially reduces patient exposure dose and improves image quality.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
whole body, head, spine, eye, extremities, gastro intestinal, abdominal, pelvic, musculoskeletal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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-101A/H,/I Aquilion 32/64 SP CT System (K080211)
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.
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APR 1 0 2012
Toshiba America Medical Systems, I Pre-Market Notification 510(k) Aquilion CXL, TSX-101A/Q
510(k) - SUMMARY OF SAFETY AND EFFECTIVENESS
-
- SUBMITTER'S NAME: Toshiba America Medical Systems, Inc.
-
- ADDRESS: 2441 Michelle Drive Tustin, CA. 92780-2068
-
- ESTABLISHMENT REGISTRATION: 2020563
-
- CONTACT PERSON: Paul Biggins Director, Regulatory Affairs (714) 730-5000
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- SUBMISSION DATE October 5, 2011
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- TRADE NAME(S): Aquilion CXL, TSX-101A/Q
-
- COMMON NAME: Scanner, Computed Tomography, X-ray
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- DEVICE CLASSIFICATION: Class II (per 21 CFR 892.1750)
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- PRODUCT CODE / DESCRIPTION: JAK - Computed tomography X-ray system
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- PERFORMANCE STANDARD: 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard
-
- PREDICATE DEVICE: TSX-101A/H,/I Aquilion 32/64 SP CT System (K080211)
-
- REASON FOR SUBMISSION: Modification of a cleared device
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Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) Aquilion CXL.TSX-101A/Q
13. DEVICE DESCRIPTION:
The Aquilion CXL is a whole body multi-slice helical CT System, consisting of a gantry, patient couch and console. The system generates up to 128 slices per rotation using a selectable slice-thickness multi-row detector. Additionally, the Aquilion CXL will utilize the new dose-reduction technologies adopted from Aquilion ONE (currently under FDA review), the system substantially reduces patient exposure dose and improves image quality.
14. SUMMARY OF INTENDED USES:
This device is designed to produce cross-sectional images of a human body by reconstruction of x-ray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blood clots in the brain, eye trauma, soft tissue lesions in the extremities, gastro intestinal lesions, abdominal and pelvic malignancies and hepatic metastases. CT is also used to evaluate intestinal obstructions, as intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no intended uses that are not in cleared devices already found in the market place.
15. SUBSTANTIAL EQUIVALENCE:
Toshiba Medical Systems Corporation believes that the Aquilion CXL, TSX-101A/Q CT Scanner is substantially equivalent to TSX-101A/H,/I Aquilion 32/64 SP CT System (K080211).
| New feature | |
|---|---|
| Maximum number of slices | Changed from 64 to 128 |
| Application of AIDR algorithm | Not available on previous version |
| Computer system is updated | Faster reconstruction |
| Additional data storage | |
| Addition of SureXtension | Previously cleared via K093891 |
| Availability of ColonView | |
| software | Cleared via K090220 |
| Table weight is extended to | |
| 300kg (660lbs.) | Previous weight was 450lbs. |
| Active collimation to reduce | |
| penumbra effect during helical | |
| scanning. | Not available on predicate |
16. SAFETY:
The device is designed and manufactured under the Quality System Requlations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the
Page 2 of 3
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Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) Aquilion CXL,TSX-101A/Q
Page 3 of 3
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 an initial report.
17. 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.
18. CONCLUSION
The Aquilion CXL, TSX-101A/Q CT Scanner complies with the same or equivalent standards and has the same intended use as the predicate device.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
APR 1 0 2012
Mr. Paul Biggins Director, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K112989
Trade/Device Name: Aquilion CXL, TSX-101A/Q Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 12, 2012 Received: March 14, 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 and 809); medical device reporting (reporting of
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Page 2
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 requirements as 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 predicate device results 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
5
Toshiba America Medical Systems, Inc.
.
| 510(k) Number (if known): | |
|---|---|
| Device Name: | Aquilion CXL, TSX-101A/Q |
Indications for Use:
Acquisition and display of axial x-ray images of the whole body to include the head.
| Prescription Use | X | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (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 Diagnostic Devices (OIVD)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
| 510(k) Number | |
|---|---|
| --------------- | -- |
Page 1 of _______
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K112989
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Indication for Use
.
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