AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM)

K013826 · Siemens Medical Systems, Inc. · KPR · Feb 1, 2002 · Radiology

Device Facts

• Record ID: K013826
• Device Name: AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM)
• Applicant: Siemens Medical Systems, Inc.
• Product Code: KPR · Radiology
• Decision Date: Feb 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Indications for Use

MPRS is a dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, and excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or supine positions. The intended use and indications for use of this modified device as described in its labeling have not changed from its predicate device.

Device Story

AXIOM Aristos FX (MPRS) is a multipurpose radiography system featuring two ceiling-mounted telescoping arms: one for the X-ray tube/collimator and one for a flat-panel detector (FD). The FD replaces conventional film/cassette systems. The system includes a modified patient table based on the Siemens Koordinat M. Used in clinical settings by trained healthcare professionals to perform whole-body radiographic examinations. The system captures X-ray exposures, which are processed and displayed for clinical review. The output assists physicians in diagnostic decision-making by providing digital radiographic images. Benefits include the elimination of film/screen processing and improved workflow efficiency.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness are supported by adherence to industry practices and final performance testing of the equipment.

Technological Characteristics

Stationary X-ray system with flat-panel detector. Components include X-ray generator, tube, collimator, and FD detector. Ceiling-mounted telescoping arm configuration. Modified Koordinat M patient table. Operates as a digital radiography system replacing film/screen. Class II device.

Indications for Use

Indicated for radiographic imaging of the whole body, including skull, spinal column, chest, abdomen, and extremities; excludes mammography. Suitable for patients in sitting, standing, or supine positions. Prescription use only.

Regulatory Classification

Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Thorax FD (K983732)
• Multix FD (K983732)

Reference Devices

• Koordinat M (K951176)

Submission Summary (Full Text)

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# FEB 0 1 2002

1

# 510(K) SUMMARY

Submitted by: Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830

Koi3826

### August 02, 2001

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

| 1. | <b>Contact Person</b><br>Ms. Sandra Robinson<br>Phone: [phone] Fax: [phone] |
|----|------------------------------------------------------------------------------------------|
|----|------------------------------------------------------------------------------------------|

#### Device Name and Classification 2.

| Trade Name: | AXIOM Aristos FX (Multipurpose Radiography System) |
|-----------------------|----------------------------------------------------|
| Internal name of R&D: | MPRS (Multipurpose Radiography System) |
| Classification Name: | Solid State x-ray Imager |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR § 892.1680 |
| | |
| Device Class: | Class II |
| Device Code: | 90MQB |

#### 3. Intended Use

MPRS is a dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, and excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or supine positions. The intended use and indications for use of this modified device as described in its labeling have not changed from its predicate device.

#### 4. Substantial Equivalence

The MPRS stationary x-ray system is a modified version of the current, commercially available SIEMENS Medical Systems:

| Thorax FD | K983732, cleared on 4/21/99 |
|----------------------------------------------------------------------------------|-----------------------------|
| Multix FD | K983732, cleared on 4/21/99 |
| The table is a modified version of the Koordinat M , K951176, cleared on 3/16/95 | |

Information that substantiates this claim of equivalence is provided throughout this 510(k) submission and specific equivalence information is provided in Attachment 1.

#### ಸ. Device Description

The MPRS Multipurpose Radiography System is designed as a set of two ceiling mounted telescoping arms. One arm is supplying the x-ray tube with the collimator, the other arm is supplying the FD (Flat panel detector), which replaces the conventional film/cassette system. A modified patient table is provided, which is based on the Siemens Koordinat M Radiographic X-ray table. Radiographic exposures may be taken with the patient in the sitting, standing, or supine positions.

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- Summary of Technological Characteristics of the Principal Device as Compared with the Predicate 6. Device
Many of the components (Generator, X-ray tube, Imaging system, Collimator, FD detector) used in MPRS Multipurpose Radiography System are either commercially available with current Siemens systems or include minor modifications to existing components.

- General Safety and Effectiveness Concerns 7.
Instructions for use are included within the device labeling and the information provided will enable the trained healthcare professional to operate the device in a safe and efficacious manner. Furthermore the operators are health care professionals familiar with and responsible for the X-ray examinations to be performed. To minimize electrical, mechanical and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing.

#### Substantial Equivalence 8.

In the opinion of Siemens Medical Systems, Inc., the hardware and software documentation and the substantial equivalence comparison matrix proves that the MPRS Multipurpose Radiography System is substantially equivalent to the Siemens Medical Systems, Inc. predicate Radiography systems - Thorax FD, and Multix FD.

Kathleen Rutherford

Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Systems, Inc.

8/8/01
Date

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 01 2002

Ms. Sandra Robinson Technical Specialist, Regulatory Submissions Siemens Medical Systems, Inc. 186 Wood Avenue South ISELIN NJ 08830

# Re: K013826

Trade/Device Name: AXIOM Aristos FX Regulation Number: 21 CFR 892.1630 Regulation Name: Electrostatic x-ray imaging system Product Code: 90 MQB Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Product Code: 90 KPR Regulatory Class: II Dated: August 6, 2001 Received: November 19, 2001

Dear Ms. Robinson:

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 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 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 to proceed to the market.

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 this 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" (21 CFR Part 807.97). 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

Enclosure

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### INDICATIONS FOR USE

| 510(k) Number (if known): | K013826 |
|---------------------------|--------------------------------------------------------|
| Device Name: | (MPRS Multi Purpose Radiology System) AXIOM ARISTOS FX |

### Indications for Use:

MPRS is a dedicated x-ray system with a flat panel detector, which allows the acquisition of x-ray exposures without MIFKS IS a dedicated x-ay systems. The MPRS allows radiographic exposures of the whole body including the use of conventional initissees. Systems. The , excluding mammography. Radiographic exposures may be taken skull, Spillal colum, citist, abouncil, or supine positions. The intended use and indications for use of this modified device as described in its labeling have not changed from its predicate device.

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

Prescription Use
(per 21 CFR 801.109)

Over-The-Counter Use _

David G. Larson

OR