(57 days)
Not Found
No
The summary describes a standard CT system and its components, focusing on image reconstruction and processing. There is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms. The performance studies are standard evaluations for CT systems.
No
The device is described as an "x-ray imaging device" that "produces cross-sectional images of the body" and "can provide an aid to diagnosis." It focuses on image acquisition, processing, and display for diagnostic purposes, not for treating any condition.
Yes
The text states that "The device output can provide an aid to diagnosis when used by a qualified physician." This directly indicates its role in the diagnostic process.
No
The device description explicitly lists hardware components such as a gantry, operator's workstation, patient table, and x-ray generator, indicating it is a hardware-based system with integrated software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device function: The ECLOS Computed Tomography system is an imaging device that uses X-rays to create images of the inside of the body. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's an "x-ray imaging device" that produces "cross-sectional images of the body."
- Device Description: The description details components like a gantry, operator's workstation, and patient table, all consistent with an imaging system, not a laboratory diagnostic device.
The device is a medical imaging system used for diagnostic purposes, but it falls under the category of in vivo (within the living body) diagnostic devices, not in vitro (in glass/outside the living body) diagnostic devices.
N/A
Intended Use / Indications for Use
The ECLOS Computed Tomography system is an x-ray imaging device that produces cross-sectional images of the body at different angles. The system reconstructs, processes, displays, and stores the collected images. The device output can provide an aid to diagnosis when used by a qualified physician and is intended for general purpose CT applications.
Product codes
JAK
Device Description
The ECLOS is a multi-slice computed tomography system that uses x-ray data to produce cross-sectional images of the body at various angles.
The ECLOS system uses "third generation" CT technology, where the x-ray tube and detector assemblies are mounted on a frame that rotates continuously around the patient using slip ring technology. The solid-state detector assembly design collects up to 16 slices of data simultaneously. The x-ray sub-system features a high frequency generator, x-ray tube, and collimation system that produces a fan beam x-ray output. The system can operate in a helical (spiral) scan mode where the patient table moves during scanning. As the x-ray tube/detector assembly rotates around the patient, data is collected at multiple angles.
The collected data is then reconstructed into cross-sectional images by a high-speed reconstruction sub-system. The images are displayed on a computer workstation, stored, printed, and archived as required. The workstation is based on current PC technology using the Windows™ operating system.
The ECLOS system consists of a gantry, operator's workstation, patient table, highfrequency x-ray generator, and accessories.
Mentions image processing
The system reconstructs, processes, displays, and stores the collected images.
The collected data is then reconstructed into cross-sectional images by a high-speed reconstruction sub-system.
Mentions AI, DNN, or ML
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Input Imaging Modality
Computed Tomography x-ray
Anatomical Site
body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
The ECLOS and the predicate device were subjected to the same non-clinical evaluations as stipulated in 21 CFR 1020.33(c). Evaluations include: dose profile, image noise, modulation transfer function (MTF), slice thickness and sensitivity profile, slice plane location, and CT dose index. The evaluation results of the ECLOS were comparable to the predicate device and support the conclusion that the ECLOS CT system is substantially equivalent. Testing has proven that the system is safe and effective for the indicated use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Hitachi PRESTO CT, 510(k) K040902
Reference Device(s)
Not Found
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
KD 71806
AUG 2 8 2007
Submitter Information
| SUBMITTER: | Hitachi Medical Systems America, Inc.
1959 Summit Commerce Park
Twinsburg, Ohio 44080-2371
ph: (330) 425-1313
fax: (330) 425-1410 |
|------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Douglas J. Thistlethwaite |
| DATE: | 06/19/2007 |
Device Name
| CLASSIFICATION NAME: | Computed tomography x-ray system |
|---|---|
| CLASSIFICATION NUMBER: | Sec. 892.1750 |
| TRADE/PROPRIETARY NAME: | ECLOS |
| PREDICATE DEVICE(S): | Hitachi PRESTO CT, 510(k) K040902 |
Device Intended Use
The ECLOS Computed Tomography system is an x-ray imaging device that produces cross-sectional image of the body at different angles. The system reconstructs, processes, displays, and stores the collected images. The device output can provide an aid to diagnosis when used by a qualified physician and is intended for general purpose CT applications.
Device Description
Function
The ECLOS is a multi-slice computed tomography system that uses x-ray data to produce cross-sectional images of the body at various angles.
Scientific Concepts
The ECLOS system uses "third generation" CT technology, where the x-ray tube and detector assemblies are mounted on a frame that rotates continuously around the patient using slip ring technology. The solid-state detector assembly design collects up to 16 slices of data simultaneously. The x-ray sub-system features a high frequency generator, x-ray tube, and collimation system that produces a fan beam x-ray output. The system can operate in a helical (spiral) scan mode where the patient table moves during scanning. As the x-ray tube/detector assembly rotates around the patient, data is collected at multiple angles.
The collected data is then reconstructed into cross-sectional images by a high-speed reconstruction sub-system. The images are displayed on a computer workstation, stored, printed, and archived as required. The workstation is based on current PC technology using the Windows™ operating system.
1
Physical and Performance Characteristics
The ECLOS system consists of a gantry, operator's workstation, patient table, highfrequency x-ray generator, and accessories. The system performance is similar to the predicate device.
Performance Comparison
Because the ECLOS and the predicate device are both Hitachi designs, they were subjected to the same non-clinical evaluations as stipulated in 21 CFR 1020.33(c). Evaluations include: dose profile, image noise, modulation transfer function (MTF), slice thickness and sensitivity profile, slice plane location, and CT dose index.
The evaluation results of the ECLOS were comparable to the predicate device and support our conclusion that the ECLOS CT system is substantially equivalent.
Device Technological Characteristics
The ECLOS CT system acquires data in the same manner as the predicate device. Physically, the ECLOS is very similar to the predicate device. The key differences are the ability to collect 16 slices in a single scan as well as improvements in overall technology.
The ability to collect 16 slices in a single scan allows overall scan time to be decreased but does not change the essential characteristics of the finished images. The predicate is a 4 slice design, meaning that if an area of 32 mm is to be examined in 2 mm increments, the x-ray tube must scan the patient 4 times, collecting 2 mm of data for each scan, to produce 16 total images. In the ECLOS's 16 slice design, the system need only to scan 2 times, collecting 32 mm of data. The x-ray beam is collimated to allow the exposure of 16 slices simultaneously, and the data collection system collects all 16 slices. Since the data collection system processes the data in 2 mm increments, the system produces 16 images as before, but during a shorter time.
The operation of the system is virtually identical to the predicate because both systems were produced using the same essential design concepts. The ECLOS operating system software is essentially the same, as well as the user interface. The patient table design is the same, with the exception that the weight limit was increased somewhat. Gantry controls provide the same features as the predicate, but the control lavout was updated.
Despite these differences, the ECLOS CT system is technologically equivalent in concept, function, and performance to the predicate device.
Conclusions
The ECLOS CT system has been developed and validated according to applicable standards. Testing has proven that the system is safe and effective for the indicated use. Risk and hazard analysis shows that there are no new safety issues associated with this system as compared with the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
AUG 2 8 2007
Mr. Doug Thistlethwaite Manager, Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park TWINSBURG OH 44087-2371
Re: K071806
ECLOS Computed Tomography X-ray System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: June 20, 2007 Received: July 2, 2007
Dear Mr. Thislethwaite:
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 either class II (Special Controls) or class III (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image shows a logo with the text "FDA Centennial" inside a circle. Above the logo, the text "1906-2006" is visible. Below the logo, the text "Protecting and Promoting Public Health" is visible. The text is in a serif font.
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Page 2 -
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); 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.
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 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy Chogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if K071806 known): ECLOS Computed Tomography X-ray System Device Name:
Indications for Use:
The ECLOS Computed Tomography system is an x-ray imaging device that produces cross-sectional images of the body at different angles. The system reconstructs, processes, displays, and stores the collected images. The device output can provide an aid to diagnosis when used by a qualified physician and is intended for general purpose CT applications.
Prescription Use × AND/OR
Over-the-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
JWhary
(Division Sign-Off Division of Reproductive, Abdominal and Radiological Devices 510(k) Number