PLANMED SOPHIE AND SOPHIE CLASSIC

K991826 · Planmed OY · IZH · Aug 10, 1999 · Radiology

Device Facts

• Record ID: K991826
• Device Name: PLANMED SOPHIE AND SOPHIE CLASSIC
• Applicant: Planmed OY
• Product Code: IZH · Radiology
• Decision Date: Aug 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1710
• Device Class: Class 2

Intended Use

The Planmed Sophie and Planmed Sophie Classic are mammographic xray systems, which are intended to be used to produce radiographs of the breast. The devices can be equipped with accessories to fulfil different diagnostic needs.

Device Story

Planmed Sophie and Sophie Classic are mammographic X-ray systems; used to produce breast radiographs. Systems utilize X-ray radiation to capture internal breast structures. Operated by trained radiologic technologists in clinical settings. Output consists of radiographic images used by radiologists for diagnostic assessment of breast tissue. Device includes MAXVIEW positioning system accessory to assist in breast compression and positioning. Clinical benefit derived from high-quality imaging for breast cancer screening and diagnostic evaluation.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Mammographic X-ray system; includes MAXVIEW positioning system accessory. Operates via ionizing radiation for image acquisition. System is a modification of existing predicate mammographic units. No specific materials or software algorithms detailed in the provided documentation.

Indications for Use

Indicated for use as mammographic X-ray systems to produce radiographs of the breast for diagnostic imaging purposes.

Regulatory Classification

Identification

A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 10 1999

Regulatory Affairs Manager

Planmed Ov

FIN-00810

Lars Morning

Asebtajabkatu 6

Re:

K991826 Sophie and Sophie Classic Modification MAXVIEW Positioning System Dated May 26, 1999 Received: Mat 28, 1999 Regulatory Class: II 21 CFR 892.1710/Procode: 90 IZH

Dear Mr. Morning:

Helsinki, FINLAND

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 legally marked predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Madical Device Amendments, or to devices that have been redassified 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 III (Special Controls) or dass 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 Requlations, 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 531 through 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 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 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/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## PLANMED OY

May 26, 1999

Ref.: 510(k) Notification Mammographic X-ray System Planmed Sophie and Sophie Classic Modification p. 12-1

## INDICATIONS FOR USE

The Planmed Sophie and Planmed Sophie Classic are mammographic xray systems, which are intended to be used to produce radiographs of the breast. The devices can be equipped with accessories to fulfil different diagnostic needs.

Lars Moring

Regulatory Affairs Manager

Date: May 26, 1999

Prescription Use
(Per 21 CFR 801.109)

David A. Seppanen

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number

Over-the-Counter Use _