(74 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or related concepts, and the device description focuses on a positioning system for a standard mammography machine.
No
The device is used to produce radiographs for diagnosis, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section states that the devices are "intended to be used to produce radiographs of the breast" and "can be equipped with accessories to fulfil different diagnostic needs," indicating their role in diagnosis.
No
The device is described as a "mammographic xray system," which is a hardware device. The modification mentioned, "MAXVIEW Positioning System," also implies a hardware component for positioning. There is no indication that the submission is solely for software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states that the Planmed Sophie and Planmed Sophie Classic are "mammographic xray systems, which are intended to be used to produce radiographs of the breast." This is an imaging device that produces images of the body, not a test performed on a sample taken from the body.
Therefore, based on the provided information, this device falls under the category of medical imaging equipment, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
90 IZH
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1710 Mammographic x-ray system.
(a)
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.(b)
Classification. Class II.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle.
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 (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/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
1
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 _