MOBILETTE XP AND MOBILETT XPHYBRID

K033238 · Siemens Medical Systems, Inc. · IZL · Nov 14, 2003 · Radiology

Device Facts

• Record ID: K033238
• Device Name: MOBILETTE XP AND MOBILETT XPHYBRID
• Applicant: Siemens Medical Systems, Inc.
• Product Code: IZL · Radiology
• Decision Date: Nov 14, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1720
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Mobilett XP and Mobilett XPhybrid are radiographic systems designed for use in wards, intensive care and premature-birth wards, pediatric and emergency departments, operating theatres as well as the central X-ray department.

Device Story

Mobilett XP and Mobilett XPhybrid are microprocessor-controlled mobile X-ray systems for routine bedside radiographic procedures. Used in intensive care, emergency, pediatric, and operating departments. Systems provide diagnostic X-ray imaging; operated by healthcare professionals. Microprocessor control manages system operation and X-ray generation. Benefits include bedside imaging capability, reducing need to transport critically ill or pediatric patients to central radiology departments.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to the predicate device.

Technological Characteristics

Microprocessor-controlled mobile X-ray system. Designed for bedside use. Class II device under 21 CFR 892.1720. Product code IZL.

Indications for Use

Indicated for radiographic imaging in clinical settings including wards, intensive care, premature-birth wards, pediatric departments, emergency departments, operating theatres, and central X-ray departments.

Regulatory Classification

Identification

A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Siemens Mobilett Plus/Mobilett Plus HP (K932106)

Submission Summary (Full Text)

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# K033238

# NOV 1 4 2003

## 510(K) SUMMARY FOR THE MOBILETT XP AND MOBILETT XPHYBRID

### Submitted by:

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

September 26, 2003

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.

#### Contact Person: 1.

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

#### 2. Device Name and Classification:

| Trade Name: | Mobilett XP and Mobilett XPHybrid |
|------------------------|-----------------------------------|
| Classification Name: | Mobile X-Ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1720 |
| Device Classification: | Class II |
| Product Code: | IZL |

#### 3. Substantial Equivalence:

The Mobilett XP and Mobilett XPhybrid x-ray systems are microprocessor controlled mobile x-ray systems developed for routine bedside radiographic procedures. The systems are substantially equivalent to the following devices:

| Predicate Device Name | FDA Clearance Number FDA Clearance Date | |
|----------------------------------------|-------------------------------------------|----------|
| Siemens Mobilett Plus/Mobilett Plus HP | K932106 | 09/14/94 |

#### 4. Device Description:

The Mobilett XP and Mobilett XP hybrid x-ray systems are microprocessor controlled mobile x-ray systems developed for routine bedside radiographic procedures in intensive care, emergency, central X-ray, and pediatric departments, as well as operating rooms.

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#### 5. Intended Use of the Device:

The Mobilett XP and Mobilett XPhybrid are radiographic systems designed for use in wards, intensive care and premature-birth wards, pediatric and emergency departments, operating theatres as well as the central X-ray department.

nealie K. Hartman

Nealie Hartman Technical Specialist, Regulatory Affairs Submissions Siemens Medical Systems, Inc.

6

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 4 2003

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

### Re: K033238

Trade/Device Name: Mobilett XP and Mobilett XP Hybrid Regulation Number: 21 CFR 892.1720 Regulation Name: Mobil x-ray system Regulatory Class: II Product Code: 90 IZL Dated: October 3, 2003 Received: October 17, 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 (OS) 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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Page 2

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 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 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 Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _ K.03 323 8 Device Name: _ Mobilett XP and Mobilett XP wbrid

# INDICATIONS FOR USE:

The Mobilett XP and Mobilett XPsybrid are radiographic systems designed for use in wards, intensive care and premature-birth wards, pediatric and emergency departments, operating theatres as well as the central X-ray department.

(Please do not write below this line - continue on another page if needed) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of the CDRH, Office of Device Evaluation (ODE)

Over-The-Counter Use_ Prescription Use _ OR 1 (Per 21 CFR 801.109) Mico

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