(69 days)
Not Found
No
The description focuses on standard CT technology (slip ring, data reconstruction, volumetric acquisition) and explicitly states that the computer components are "mature technologies that are standard to and well known throughout the medical device industry." There is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML devices.
No
The device is used for diagnosis and imaging, not for treating or curing a disease or medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the images produced by the device "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, gastrointestinal lesions, abdominal and pelvic malignancies, and hepatic metastases." This directly indicates its role in diagnosis.
No
The device description clearly outlines hardware components such as an x-ray tube, x-ray detector, slip ring technology, and a microprocessor-based computer, indicating it is a physical medical device, not software-only.
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 taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is an X-ray imaging system (CT Scanner) that produces images of the human body by reconstructing X-ray transmission data. It works by scanning the body directly, not by analyzing samples taken from the body.
- Intended Use: The intended uses listed are all related to diagnosing conditions based on the visual information provided by the CT images, not through laboratory analysis of biological samples.
Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial plane taken at different angles. These image have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blodd clots in the brain, eye trauma, soft tissue lesions in the extremities, gastrointestinal lesions, abdominal and pelvic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstructions, assess intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no intended uses that are not in cleared devices already found in the marketplace.
X-ray imaging of whole body - Computerized Tomography Including: Axial Volumetric (Helical)
Product codes (comma separated list FDA assigned to the subject device)
90JXD, 90JAK
Device Description
The Auklet is a whole body CT Scanner that employs slip ring technology which allows continuous rotation of the x-ray tube and x-ray detector. The x-ray detector collects transmission data as it and the x-ray tube rotate 360 degrees axially around a human body. Computer controlled data processing reconstructs the transmission data into a two dimensional image representing a "clice" of the body. As is common with today's CT Scanner, the Auklet has the capability to acquire volumetric (helical) data by initiating table movement during data acquisition. This data can be reconstructed per the operator's preference, to include three dimensional rendering of the patient data. This device incorporates a standard x-ray tube and xenon gas filled x-ray detector for the acquisition of data. The microprocessor based computer, hard disk storage of software and data, and display electronics are mature technologies that are standard to and well known throughout the medical device industry.
Mentions image processing
computer controlled data processing reconstructs the transmission data into a two dimensional image representing a "clice" of the body.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray transmission data
Anatomical Site
whole body, spine, head, brain, eye, extremities, gastrointestinal tract, abdomen, pelvis, 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
Not Found
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.
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
K97 3908
DEG 22 1997
510(k) Summary
ﻤﺴﺴﺴ
| Date: | 20 August 1997 | |
|---|---|---|
| Submitter's Name: | Toshiba America Medical Systems, Inc. | |
| Submitter's Address: | P.O. Box 2068, 2441 Michelle Drive, | |
| Tustin, CA 92781-2068 | ||
| Submitter's Contact: | Paul Biggins, Regulatory Affairs Specialist, (714)730-5000 | |
| Establishment Registration | ||
| Number: | 2020563 | |
| Device Proprietary Name: | Auklet CT Scanner, TSX-003A | |
| Common Name: | Scanner, Computed Tomography, X-Ray | |
| [Fed. Reg. No. 892.1750, Pro. Code: 90JXD] | ||
| Regulatory Class: | II (per 21 CFR 892.1750) | |
| Predicate Device: | Toshiba TSX-002A, Xvision [K941745] | |
| Reason For Submission | New Product |
Description of this Device:
The Auklet is a whole body CT Scanner that employs slip ring technology which allows continuous rotation of the x-ray tube and x-ray detector. The x-ray detector collects transmission data as it and the x-ray tube rotate 360 degrees axially around a human body. Computer controlled data processing reconstructs the transmission data into a two dimensional image representing a "clice" of the body. As is common with today's CT Scanner, the Auklet has the capability to acquire volumetric (helical) data by initiating table movement during data acquisition. This data can be reconstructed per the operator's preference, to include three dimensional rendering of the patient data. This device incorporates a standard x-ray tube and xenon gas filled x-ray detector for the acquisition of data. The microprocessor based computer, hard disk storage of software and data, and display electronics are mature technologies that are standard to and well known throughout the medical device industry.
Summary of Intended Uses:
This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial plane taken at different angles. These image have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blodd clots in the brain, eye trauma, soft tissue lesions in the extremities, gastrointestinal lesions, abdominal and pelvic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstructions, assess intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no intended uses that are not in cleared devices already found in the marketplace.
1
Technological Characteristics:
11
This device employs the same technological characteristics as the predicate device, differing only in the specifics of subassembly component composition. Both of these system employ the use of high frequency x-ray controllers to generate x-radiation from the x-ray tube. The x-ray transmission data is detected by the x-ray detector and is reconstructed by the computer. Both of these devices produce two dimensional, black and white image that can be filmed or electronically stored for future review.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard .... Rockville MD 20850
Paul Biggins Regulatory Affairs Specialist Toshiba America Medical Systems, Inc. 2441 Michelle Drive P.O. Box 2068 Tustin, CA 92781-2068
Re:
DEC 2 2 1997 K973908 TSX-003A Auklet CT Scanner Dated: October 13, 1997 Received: October 14, 1997 Regulatory class: II 21 CFR 892.1750/Procode: 90 JAK
Dear Mr. Biggins:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the ise stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note; this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marked 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely vours
Wiliau Yu
Lillian Yiu, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Page 1 of 1510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Indications for Use:
二
X-ray imaging of whole body - Computerized Tomography Including: Axial Volumetric (Helical)
(PLEASE DO NOT WRITE BELOW THIS LINE , CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device, Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K973908 |
| Prescription Use (Per 21 CFR 801.109) | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| --------------------------------------- | -------------- | ---- | ---------------------- |
(Optional Format
(Optional Format 1-2-96)