SOMATON COMPUTED TOMOGRAPHY X-RAY SYSTEMS SLIDING GANTRY OPTION

K032475 · Siemens Medical Solutions USA, Inc. · JAK · Nov 10, 2003 · Radiology

Device Facts

• Record ID: K032475
• Device Name: SOMATON COMPUTED TOMOGRAPHY X-RAY SYSTEMS SLIDING GANTRY OPTION
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: JAK · Radiology
• Decision Date: Nov 10, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The CT device with Sliding Gantry Option is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles. (*Spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube and the simultaneous movement of the Sliding Gantry).

Device Story

Sliding Gantry Option modifies standard CT systems by mounting the gantry on a rail system; enables whole-body scanning across different patient tables and environments. Instead of moving the patient table relative to the gantry, the gantry moves relative to the table. Input consists of x-ray transmission data; system performs computer reconstruction to produce cross-sectional images. Used in clinical settings; operated by trained radiology staff. Facilitates imaging flexibility by allowing the gantry to be positioned over different tables, potentially improving workflow in multi-modal environments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Rail-mounted CT gantry system; motorized horizontal movement integrated into gantry assembly; enables relative motion between gantry and patient table. Operates as an accessory to existing CT x-ray systems. Standard CT imaging components (x-ray tube, detectors).

Indications for Use

Indicated for patients requiring cross-sectional body imaging via CT scanning. No specific age, gender, or disease state contraindications provided.

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

• Siemens Angio-CT MIYABI (K990491)
• Siemens Plus 4 with Sliding Gantry Option (K991600)

Submission Summary (Full Text)

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## 510(K) SUMMARY FOR THE SLIDING GANTRY OPTION FOR CT DEVICES

## Submitted by:

Siemens Medical Solutions, Inc. 51Valley Stream Parkway Malvern, PA 19355

July XX, 2003

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

#### Contact Person: 1.

Ms. Nealie Hartman 51 Valley Stream Parkway Malvern, PA 19355 Phone: [phone] Fax: [phone]

#### Device Name and Classification 2.

Product Name: Common Name Classification Name: Classification Panel: CFR Section: Device Class: Product Code:

Sliding Gantry Option for CT Devices Computed Tomography X-ray system Accessory to Computed Tomography System Radiology 21 CFR §892.1750 Class II 90 JAK

#### Importer/Distributor Establishment: 3.

Registration Number: 2240869 Siemens Medical Solutions, Inc. 51 Valley Stream Pkwy Malvern, PA 19355

#### Manufacturing Facility: 4.

Siemens AG Medical Solutions Henkestrasse 127 D-91052 Erlangen, Germany

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K032475

#### 5. Substantial Equivalence

The Sliding Gantry Option for CT Devices, addressed in this premarket notification, is substantially equivalent to the following commercially available systems

| Predicate Device Name | FDA Clearance Number | FDA Clearance Date |
|----------------------------------------------|----------------------|--------------------|
| Siemens Angio-CT MIYABI | K990491 | 04/05/99 |
| Siemens Plus 4 with Sliding Gantry<br>Option | K991600 | 06/09/99 |

#### 6. Device Description

The Sliding Gantry option is designed to allow whole body x-ray computed tomography scanning on a single patient that can be performed on different types of patient tables in different environments. The Sliding Gantry Option integrates the function of precise scan control driven horizontal movement, which is usually a function of the dedicated CT-table, into the CT gantry itself. The original CT gantry is mounted on a rail system and a scan control system moves the gantry relative to the table, instead of moving the table relative to the gantry.

#### 7. Intended Use

The CT device with Sliding Gantry Option is intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes* taken at different angles. (*Spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube and the simultaneous movement of the Sliding Gantry).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Nealie Hartman Technical Specialist Siemens Medical Systems, Inc. 51 Valley Stream Parkway MALVERN PA 19355

NOV 1 0 2003

Re: K032475

Trade/Device Name: SOMATOM Computed Tomography X-ray Systems with Sliding Gantry Option Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

x-ray syste

Regulatory Class: II Product Code: 90 JAK Dated: August 8, 2003 Received: August 16, 2003

Dear Ms. Hartman:

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 (PMA), 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 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.

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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

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 the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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

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to proceed to the market.

Enclosure

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# SECTION 2

## INDICATIONS FOR USE

### 1032475 510(k) Number (if known): _ Sliding Gantry Option for Siemens CT systems Device Name:

The CT device with Sliding Gantry Option is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles. (*Spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube and the simultaneous movement of the Sliding Gantry).

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Concurrence of the CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR §801.109)

Over-The-Counter Use OR

Nancy C. Broadon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K032475

510(k) for SIEMENS "Sliding Gantry Option" for

CONFIDENTIAL