VOLUMAX CT IMAGING SYSTEM

K982060 · Elscint, Inc. · JAK · Sep 2, 1998 · Radiology

Device Facts

• Record ID: K982060
• Device Name: VOLUMAX CT IMAGING SYSTEM
• Applicant: Elscint, Inc.
• Product Code: JAK · Radiology
• Decision Date: Sep 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

Whole body computerized tomography.

Device Story

Volumax is a continuous rotation CT scanner comprising a gantry, patient table, and operator station. It performs whole body imaging using spiral (helical) scanning and simultaneous multi-slice acquisition. The system achieves a minimum scan time of 0.3 seconds and a minimum reconstruction time of 0.5 seconds. Operated by trained clinical staff in a radiology setting, the device captures X-ray data to produce cross-sectional images. These images assist clinicians in diagnostic assessment and clinical decision-making. The system is designed for high-speed volumetric data acquisition to benefit patients through reduced scan times.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness were demonstrated through adherence to GMP practices, international standards (IEC 601-1), and compliance with 21 CFR Subchapter J performance standards for radiation safety.

Technological Characteristics

Continuous rotation CT scanner; spiral (helical) scanning; simultaneous multi-slice acquisition; 0.3s minimum scan time; 0.5s minimum reconstruction time. Electrical/mechanical safety per IEC 601-1; radiation safety per 21 CFR Subchapter J. System includes gantry, patient table, and operator station.

Indications for Use

Indicated for whole body computerized tomography imaging.

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

• CT-Twin flash (K945512)
• SeleCT/SP (K961464)
• OmniPro (ProVision) (K954678)

Reference Devices

• XRT-7 Option for CT scanner (K964583)
• Siemens Somatom Plus 4 (K941546, K964747)
• Siemens Magnetom Project 016 (K932271)

Submission Summary (Full Text)

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K982060

#### 2 1998 SEP

# 510(k) Summary

# Summary of Safety and Effectiveness

## 1. Device Name

Volumax CT scanner

### 2. Submitter

_ Elscint Inc., 505 Main Str. Hackensack, NJ 07601

# 3. Intended Use Of Device and its Main Features

The Volumax is used for whole body computed tomography.

The Volumax is a continuous rotation CT scanner consisting of a gantry, patient table, operator station and accessories. Its main characteristics are:

- Continuous rotation and Helix (spiral) scanning. .
- Simultaneous multi-slice scanning. .
- Minimum scan time of 0.3 second. .
- Minimum reconstruction time of 0.5 second. .

### 4. Predicate Devices

- CT-Twin flash submitted in "HRSW Option for CT-Twin Flash" K945512. �
- � SeleCT/SP. K961464
- OmniPro which is a trade name of ProVision, K954678 �

Related devices:

- XRT-7 Option for CT scanner, K964583
- Siemens Somatom Plus 4, K941546, K964747
- Siemens Magnetom Project 016, K932271

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# 510(k) Summary

# 5. Safety and Effectiveness Considerations

The safety of the option is assured by adherence to GMP practices and to International Standards. Potential hazards are identified in a hazard analysis and controlled in the following manner:

Software safety is assured by the company procedures that conform to accepted practices. Quality assurance procedures were adhered to, and test results demonstrate that the option specifications and functional requirements were met.

Electrical and Mechanical safety is assured by adherence to IEC 601-1 standards.

Radiation safety is assured by compliance with 21 CFR, Subchapter J performance standards.

## 6. Substantial Equivalency Statement

Based on the above considerations, it is Elscint's opinion that the Volumax CT scanner scanners is substantially equivalent in safety and effectiveness to the predicate devices, CT Twin flash, K945512 and SeleCT/SP, K961464.

In our opinion it is also substantially equivalent to Siemens Somatom Plus 4, K941546, K964747.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 1998

Steven M. Kay Director, Regulatory Affairs and Quality Assurance Elscint, Inc. Corporate Headquarters 505 Main Street Hackensack, New Jersey 07601 Re:

K982060

Volumax CT Imaging System Dated: June 10, 1998 Received: June 11, 1998 Regulatory Class: II 21 CFR 892.1750/Procode: 90 JAK

Dear Mr. Kay:

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 indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through veriodic 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 542 of the Act for devices under the Electronic Product 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 marketed predication 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrb/dsmaldsmamain.html".

Sincerely yours,

Kilian Yi

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ________________________________________________________________________________________________________________________________________________________________

1

Indications for Use:

Whole body computerized tomography.

### (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 | K98 20160 |

| Prescription Use | OR | Over-The-Counter Use |
|----------------------|----|----------------------|
| (Per 21 CFR 801.109) | | |

| ✓ |
|---|
|---|

(Optional Format 1-2-96)

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