(28 days)
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.
Mammographic X-ray System Planmed Sophie and Sophie Classic Modification
This is an FDA clearance letter for a mammographic X-ray system, not a study report. It states that the device is substantially equivalent to legally marketed predicate devices.
Therefore, the document does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria, such as device performance, sample sizes, ground truth establishment, or any details about multi-reader multi-case studies or standalone algorithm performance.
The document primarily focuses on:
- Device: Planmed Sophie and Planmed Sophie Classic Mammographic X-ray Systems (Modification).
- Regulatory Classification: Class II, 21 CFR 892.1710, Procode: 90 IZH.
- Date of Clearance: November 16, 1998.
- Indications for Use: To produce radiographs of the breast.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 16 100
Lars Moring Planmed OY Asentajankatatu 6 FIN-00810 Helsinki Finland
Re: K983659
Planmed Sophie and Planmed Sophie Classic Modification Dated: October 14, 1998 Received: October 19, 1998 Regulatory class: II 21 CFR 892.1710/Procode: 90 IZH
Dear Mr. Moring:
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 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (2) 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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrf/dsmaldsmamain.html".
Sincerely yours,
Kilian Yin
Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal. Ear. Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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PLANMED OY
October 14, 1998
- Abbreviated 510(k) Notification Ref.: 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: October 14, 1998
David A. Seymore
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
N/A