MAYFIELD SCANMATE MOBILE CT SYSTEM

K053210 · Schaerer Mayfield USA, Inc. · JAK · Jan 6, 2006 · Radiology

Device Facts

• Record ID: K053210
• Device Name: MAYFIELD SCANMATE MOBILE CT SYSTEM
• Applicant: Schaerer Mayfield USA, Inc.
• Product Code: JAK · Radiology
• Decision Date: Jan 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The Mayfield® ScanMate™ Mobile CT System is a whole body CT scanning system. It is intended for use as a Computed Tomography X-ray System for diagnostic purposes, producing cross-sectional images of the body through computer reconstruction of X-ray transmission data from the same axial plane taken at different angles.

Device Story

Mayfield® ScanMate™ Mobile CT System is a mobile whole-body CT scanner. Device utilizes a translatable rotating disk containing an X-ray generator and tube to acquire X-ray transmission data from multiple angles. System performs computer reconstruction of acquired data to produce cross-sectional diagnostic images. Intended for clinical use by healthcare professionals to assist in diagnostic decision-making. Mobile form factor allows for point-of-care imaging.

Technological Characteristics

Mobile whole-body CT system; translatable rotating disk architecture; X-ray generator and tube assembly; computer-based image reconstruction of X-ray transmission data.

Indications for Use

Indicated for use as a whole body Computed Tomography X-ray System for diagnostic imaging purposes in patients requiring cross-sectional body scans.

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

• Analogic Corporation's ANATOM 2000

Submission Summary (Full Text)

{0}------------------------------------------------

# KoS3210

#### JAN G 2006 510(k) SUMMARY

Schaerer Mayfield USA, Inc.'s Mayfield® ScanMate™ Mobile CT System

## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Schaerer Mayfield USA, Inc. 4900 Charlemar Drive Cincinnati, OH 45227

Phone: [phone] Facsimile: [phone]

Contact Person: Teck W. Awa

Date Prepared: November 1, 2005

## Name of Device and Name/Address of Sponsor

Mayfield® ScanMate™ Mobile CT System

Schaerer Mayfield USA, Inc. 4900 Charlemar Drive Cincinnati, OH 45227

### Common or Usual Name

Computed Tomography X-ray System

### Classification Name

Computed Tomography X-ray System

#### Predicate Device(s)

Analogic Corporation's ANATOM 2000

# Intended Use / Indications for Use

The Mayfield® ScanMate™ Mobile CT System is a whole body CT scanning system. It is intended for use as a Computed Tomography X-ray Sus on for diagnostic purposes, producing cross-sectional images of the body through computer

{1}------------------------------------------------

econstruction of X-ray transmission data from the same axial plane taken at
different angles.

yfield® ScanMate™ Mobile CT S Tomography X-ray System for diagnostic purposes, production mages of the body through computer reconstruction of X-ray tra on the samharial prisotten at different angles.

The samharial prises

es a translatable rotating disk with X-ray generator and tube, pre

TM Mobile 0M 2000. The Mayfield® ScanMate™ Mobile CT System 1s as ses, indications for use, technological characteristics, and principles of n as its predicate device, ecomicrogical charactcrisites, and primetples of
as its predicate device, except that the ScanMate Mobile CT System uses adolocal expressor a concernal more de market monie CT System des
hoologia Alfare Proventus montant and more of President Proven need
Trans and Proven Hana de Hostine Portug

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Schaerer Mayfield USA, Inc. % Mr. Jeffrey K. Shapiro Regulatory Counsel Hogan & Hartson L.L.P. 555 Thirteenth Street, NW WASHINGTON DC 20004

Re: K053210

2006

JAN 6

Trade/Device Name: Mayfield® ScanMate™ Mobile CT System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: November 16, 2005 Received: November 16, 2005

Dear Mr. Shapiro:

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 does not mean that FDA has made a determination that vour 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

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 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 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/industry/support/index.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

{4}------------------------------------------------

### · Indications for Use Statement

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Mayfield® ScanMate™ Mobile CT System

Indications for Use:

The Mayfield® ScanMate™ Mobile CT System is intended for use as a Computed Tomography X-ray System for diagnostic purposes, producing cross-sectional images of the body through computer reconstruction of X-ray transmission data from the same axial plane taken at different angles.

Prescription Use __ X_ (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use_ (21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page _____ of

David A. Lyon

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

\\\DC - 24236/0001 - 2212551 v 1