CXR16

K053148 · Hitachi Medical Systems America, Inc. · JAK · Feb 17, 2006 · Radiology

Device Facts

• Record ID: K053148
• Device Name: CXR16
• Applicant: Hitachi Medical Systems America, Inc.
• Product Code: JAK · Radiology
• Decision Date: Feb 17, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The CXR16 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.

Device Story

CXR16 is a multi-slice CT system; uses third-generation technology with rotating x-ray tube/detector assembly and slip ring. Collects up to 16 slices of data simultaneously via solid-state detectors. High-frequency generator produces fan beam x-ray output. Operates in helical (spiral) scan mode. High-speed reconstruction sub-system processes raw data into cross-sectional images. Images displayed, stored, and archived on PC-based workstation running Windows OS. Used in clinical settings by qualified physicians. Output aids in diagnosis by providing cross-sectional anatomical visualization. Benefits include reduced scan times compared to 4-slice systems due to 16-slice simultaneous acquisition.

Clinical Evidence

Bench testing only. Evaluations included dose profile, image noise, modulation transfer function (MTF), slice thickness and sensitivity profile, slice plane location, and CT dose index. Results were comparable to the predicate device.

Technological Characteristics

Third-generation CT; solid-state detector array; high-frequency x-ray generator; fan beam geometry; helical scan mode. PC-based workstation (Windows OS). 16-slice simultaneous data acquisition. Performance metrics: dose profile, MTF, image noise, CT dose index.

Indications for Use

Indicated for use as an x-ray imaging device to produce cross-sectional images of the body for diagnostic aid by a qualified physician.

Regulatory Classification

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.

Predicate Devices

• Hitachi Presto CT (K040902)

Submission Summary (Full Text)

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Ko53148

FEB 1 7 2006

# HITACHI

#### HITACHI MEDICAL SYSTEMS AMERICA, INC.

1959 Summit Commerce Park Twinsburg, Ohio 44087-2371 Tel. [phone] Fax: [phone]

# 510(k) Summary

# Submitter Information

| Submitter: | Hitachi Medical Systems America, Inc.<br>1959 Summit Commerce Park<br>Twinsburg, Ohio 44080-2371<br>ph: [phone]<br>fax: [phone] |
|------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Douglas J. Thistlethwaite |

Date: September, 15-2005

### Device Name

| Device Name: | Computed tomography x-ray system |
|-------------------------|-------------------------------------|
| Trade/Proprietary Name: | CXR16 |
| Common Name: | Computed Tomography X-ray System |
| Classification Name: | System, X-Ray, Tomography, Computed |
| Classification Number: | Sec. 892.1750 |

## Predicate Device

Predicate Device: Hitachi Presto CT, 510(k) K040902

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# Device Description

#### Function

The CXR16 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 CXR16 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.

#### Physical and Performance Characteristics

The CXR16 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 CXR16 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 CXR16 were comparable to the predicate device and support our conclusion that the CXR16 CT system is substantially equivalent.

## Device Intended Use

The CXR16 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.

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# Device Technological Characteristics

The CXR16 CT system acquires data in the same manner as the predicate device. Physically, the CXR16 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 16 mm is to be examined in 2 mm increments, the x-ray tube must scan the patient 2 times, collecting 8 mm (4x2)of data for each scan, to produce 8 total images. In the CXR16 system's 16-slice design, the system need only to scan I times, collecting 16 mm of data during each scan. The x-ray beam is collimated to allow the exposure of 16 Slices simultaneously, and the data collects all 16 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 because both systems were produced using the same essential design concepts. The CXR16 operating system software is essentially the same, as well as the user interface. The patient table and gantry designs were updated. See the predicate comparison for detailed information.

Despite these differences, the CXR16 CT system is technologically equivalent in concept, function, and performance to the predicate device.

# Conclusions

The CXR16 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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 7 2006

Hitachi Medical Systems America, Inc. % Mr. Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719

Re: K053148 Trade/Device Name: CXR 16 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: February 1, 2006 Received: February 3, 2006

Dear Mr. Devine:

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.

Please be advised that FDA's issuance of a substantial equivalence determination docs 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 clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to organization of substantial equivalence of your device to a legally premarked notheation: "The Pine meaning and this 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 actrice for your ar of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the 607.77). Tod may ookin varers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

7. Nancy C. Brigdon

Nanev C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

I nelosure

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#### Indications for Use

510(k) Number (if known):

: K053148

CXR16 Computed Tomography X-ray System Device Name:

Indications for Use:

The CXR16 Computed Tomography system is an x-ray imaging device that produces The CAN To Oumputed Tomography I different angles. The system reconstructs, cross-sectional images of the body at and on interest. The device output can provide processed, dioplayer when used by a qualified physician.

× Prescription Use (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)

David A. Ingram

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

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