(60 days)
No
The summary describes a standard CT imaging system with an option for interventional procedures. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The image processing mentioned is standard for CT reconstruction.
No
The device is described as an "x-ray imaging device" that "produce cross-sectional images of the body" and its output "can provide an aid to diagnosis." It supports interventional imaging by allowing the operator to view images, but it does not directly apply therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The device output can provide an aid to diagnosis when used by a qualified physician."
No
The device is a computed tomography system, which is a hardware device that uses x-rays to produce images. The guideShot Option adds hardware components (remote monitor and controls).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. The provided description clearly states that this device is an x-ray imaging system that produces images of the body itself, not specimens taken from the body.
- The intended use is for in-vivo imaging. The device is used to image the patient directly, not to analyze samples in a laboratory setting.
- The device description focuses on imaging technology and interventional procedures. This aligns with the function of a CT scanner used for diagnostic and interventional radiology, not in vitro diagnostics.
The device is a medical imaging system used for diagnostic and interventional purposes, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The CXR4 Computed Tomography System with guideShot Option are x-ray imaging devices that produce cross-sectional images of the body at different angles. The systems reconstruct, process, display, and store the collected images. The guideShot Option adds a remote in-room display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a qualified physician.
Product codes
JAK
Device Description
The CXR4 and 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 guideShot Option adds a remote monitor and controls at the patient table to allow the operator to initiate data collection and to view resulting CT images in order to support interventional procedures.
Mentions image processing
The CXR4 and ECLOS Computed Tomography Systems with guideShot Option are xray imaging devices that produce cross-sectional images of the body at different angles. The systems reconstruct, process, display, and store the collected images.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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)
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 CXR4 and ECLOS with guideShot Option were comparable to the predicate device and support our conclusion that the system is substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Hitachi Presto (CXR4) Computed Tomography X-ray System, 510(k) K040902, Hitachi ECLOS Computed Tomography X-ray System, 510(k) K071806
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
K09/1C3
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Submitter Information
| SUBMITTER: | Hitachi Medical Systems America, Inc.
1959 Summit Commerce Park
Twinsburg, Ohio 44080-2371
ph: (330) 425-1313
fax: (330) 963-0749 | JUN 1 5 2009 |
|------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| CONTACT: | Douglas J. Thistlethwaite | |
| DATE: | April 9, 2009 | |
Device Name
| CLASSIFICATION NAME: | Computed tomography x-ray system |
|---|---|
| CLASSIFICATION NUMBER: | Sec. 892.1750 |
| TRADE/PROPRIETARY NAME: | guideShot |
| PREDICATE DEVICE(S): | Hitachi Presto (CXR4) Computed Tomography X-ray System, 510(k) K040902 |
| Hitachi ECLOS Computed Tomography X-ray System, 510(k) K071806 |
Device Intended Use
The CXR4 and ECLOS Computed Tomography Systems with guideShot Option are xray imaging devices that produce cross-sectional images of the body at different angles. The systems reconstruct, process, display, and store the collected images. The guideShot Option adds a remote in-room display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a qualified physician.
Device Description
Function
The CXR4 and 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 guideShot Option adds a remote monitor and controls at the patient table to allow the operator to initiate data collection and to view resulting CT images in order to support interventional procedures.
Scientific Concepts
The CXR4 and 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 depending on the model. 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
1
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.
Physical and Performance Characteristics
The CXR4 and ECLOS systems consist of a gantry, operator's workstation, patient table, high-frequency x-ray generator, and accessories. The guideShot option adds a remote monitor and footswitch to control acquisitions and display images in the scan room. The system performance is similar to the predicate device.
Performance Comparison
Because the CXR4 and ECLOS with guideShot Option 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 CXR4 and ECLOS with guideShot Option were comparable to the predicate device and support our conclusion that the system is substantially equivalent.
Device Technological Characteristics
The CXR4 and ECLOS with guideShot Option acquires data in the same manner as the predicate device. Physically, the CXR4 and ECLOS with guideShot Option is very similar to the predicate device. The key differences are the ability to initiate a scan and display data in the scan room.
The ability to collect and display image on an in-room monitor does not change the essential characteristics of the finished images. The operation of the system is virtually identical to the predicate because guideShot simply adds remote display and controls to the predicate device. The CXR4 and ECLOS operating system software is essentially the same, as well as the user interface. The patient table design and gantry controls are unchanged.
In conclusion, the CXR4 and ECLOS with guideShot Option is technologically equivalent in concept, function, and performance to the predicate device.
Conclusions
The CXR4 and ECLOS with guideShot Option 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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Image /page/2/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 three human profiles facing right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 302009
Mr. Doug Thistlewaite Manager, Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park TWINSBURG OH 44087
Re: K091103
Trade/Device Name: guideShot Option, CXR4 Computed X-ray System and guideShot Option, 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: April 9, 2009 Received: April 16, 2009
Dear Mr. Thistlewaite:
This letter corrects our substantially equivalent letter of June 15, 2009.
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 (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 (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
3
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Janine M. Morris
Janine M. Morris Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if K091103 known): Device Name:
guideShot Option, CXR4 Computed Tomography X-ray System
Indications for Use:
The CXR4 Computed Tomography System with guideShot Option are x-ray imaging devices that produce cross-sectional images of the body at different angles. The systems reconstruct, process, display, and store the collected images. The guideShot Option adds a remote in-room display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a 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 Device Evaluation (ODE)
Nogn M. Khan
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number