(14 days)
Not Found
No
The description focuses on standard CT technology and image processing techniques, with no mention of AI or ML.
No
The device is described as an x-ray imaging system for diagnosis, not for treating any conditions.
Yes
Explanation: The "Intended Use" section explicitly states that "The device output can provide an aid to diagnosis when used by a qualified physician." This indicates that the device assists in the diagnostic process.
No
The device description explicitly lists hardware components such as a gantry, operator's workstation, patient table, high-frequency x-ray generator, and accessories, indicating it is a physical medical device system, not software-only.
Based on the provided information, the Presto Computed Tomography system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Presto System Function: The Presto system is an x-ray imaging device. It uses x-rays to create images of the inside of the living body (in vivo). It does not analyze samples 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." This is consistent with in vivo imaging, not in vitro testing.
Therefore, the Presto Computed Tomography system falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Presto 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.
Product codes
JAK
Device Description
The Presto is a multi-slice computed tomography system that uses x-ray data to produce cross-sectional images of the body at various angles.
The Presto 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 4 slices of data simultaneously. The x-ray sub-system features a high frequency generator, xray 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-specd 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 Presto system consisting of a gantry, operator's workstation, patient table, high-frequency x-ray generator, and accessories. The system performance is similar to the predicate device.
Mentions image processing
Yes
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)
The Presto 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 Presto were comparable to the predicate device and support the conclusion that the Presto CT system is substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Hitachi Pronto CT, 510(k) K014240
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
APR 2 1 2004
HITACHI
HITACHI MEDICAL SYSTEMS AMERICA, INC.
1959 Summit Commerce Park Twinsburg, Ohio 44087-2371 Tel.: 330.425.1313 Fax: 330.425.1410
510(k) Summary
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: | February 24, 2004 |
Device Name
| Device Name: | Computed tomography x-ray system |
|---|---|
| Trade/Proprietary Name: | Presto |
| Common Name: | Computed Tomography X-ray System |
| Classification Name: | System, X-Ray, Tomography, Computed |
| Classification Number: | Sec. 892.1750 |
Predicate Device
Predicate Device: Hitachi Pronto CT, 510(k) K014240
1
Device Description
Function
The Presto 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 Presto 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 4 slices of data simultaneously. The x-ray sub-system features a high frequency generator, xray 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-specd 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 Presto system consisting of a gantry, operator's workstation, patient table, high-frequency x-ray generator, and accessories. The system performance is similar to the predicate device.
Performance Comparison
Because the Presto and the predicate device are both Hitachi designs, they were subjected to the same non-clinical cvaluations 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 Presto were comparable to the predicate device and support our conclusion that the Presto CT system is substantially equivalent.
Device Intended Use
The Presto 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.
2
Device Technological Characteristics
The Presto CT system acquires data in the same manner as the predicate device. Physically, the Presto is very similar to the predicate device. The key differences are the ability to collect 4 slices in a single scan as well as improvements in overall technology.
The ability to collect 4 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 single slice design, meaning that if an area of 16 mm is to be examined in 2 mm increments, the x-ray tube must scan the patient 8 times, collecting 2 mm of data for each scan, to produce 8 total images. In the Presto's 4 slice design, the system need only to scan 2 times, collecting 8 mm of data during each scan. The x-ray beam is collimated to allow the exposure of 4 slices simultaneously, and the data collection system collects all 4 slices. Since the data collection system processes the data in 2 mm increments, the system produces 8 images as before, but during a shorter time.
The operation of the system is virtually identical to the predicate both systems were produced using the same essential design concepts. The Presto 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 layout was updated.
Despite these differences, the Presto CT system is technologically equivalent in concept, function, and performance to the predicate device.
Conclusions
The Presto 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.
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and body. The logo is rendered in black and white.
APR 2 1 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hitachi Medical Systems America, Inc. c/o Mr. Daniel Lehtonen Staff Engineer - Medical Devices Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01779
Re: K040902
Trade/Device Name: Presto Computed Tomography X-ray System Regulation Number: 21 CFR §892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: April 6, 2004 Received: April 7, 2004
Dear Mr. Lehtonen:
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 (sec 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 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.
4
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin matters of substantial equivalence of your device to a legally premarket notification. THCPDA intellight of the more 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 If you desire specific advice tor your dones as one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the prosses note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general by releveloe to promation to the Act may be obtained from the Division of Strail Information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or Mandracturers, International and Solasmiller Schools. Ida.gov/cdrh/dsmaldsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
5
K040902 510(k) Number (if known): Presto Computed Tomography X-ray System Device Name:
Indications for Use:
The Presto Computed Tomography system is an x-ray imaging device that produces cross-sectional images of the The I resto Computed Tonography System a art, processes, displays, and stores the collected images. The device output can provide an aid to diagnosis when used by a qualified physician.
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