(29 days)
Not Found
No
The summary describes standard digital imaging processing and does not mention AI, ML, or related terms.
No
The device is described as an X-ray imaging system used for diagnosis and guiding biopsies, not for treating a disease or condition.
Yes
The device is used for "diagnostic spot localization" and "spot imaging for diagnosis," which are direct indications of its use for diagnosing medical conditions.
No
The device description explicitly states it includes a CCD detector, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Siemens MAMMOMAT series with OPDIMA option is an imaging device. It uses X-rays to create images of the breast for diagnostic and biopsy purposes. It does not analyze biological samples.
- Intended Use: The intended use clearly states "small field mammographic X-ray imaging" and its use during "stereotactic biopsy and diagnostic spot localization." This is a description of an imaging procedure, not an in vitro test.
Therefore, based on the provided information, this device falls under the category of a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Siemens MAMMOMAT series with OPDIMA option is intended for use in small field mammographic X-ray imaging (SFDM). Such small field imaging is used during stereotactic biopsy and diagnostic spot localization.
Product codes
90IZIL
Device Description
OPDIMA is a Small Field Digital Mammography (SFDM) system. It is marketed as an option to the Siemens MAMMOMAT Novation X-ray examination system. It provides spot imaging for diagnosis and stereotactic biopsy. OPDIMA features a small (49 x 85 mm²) CCD detector that converts the X-ray attenuation into an electronic pattern. The electronic pattern is read out, processed, and displayed on a high resolution monitor. The images may be post processed, printed, or transferred via DICOM network for multiple purposes.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Breast (small field mammographic x-ray imaging)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained healthcare professional / 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1720 Mobile x-ray system.
(a)
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.(b)
Classification. Class II.
0
510(K) SUMMARY FOR THE OPDIMA
SEP 2 5 2007
Submitted by:
Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355
August 23, 2007
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.
1. Contact Person:
Ms. Kim Rendon 51 Valley Stream Parkway Malvern, PA 19355 Phone: (610) 448-1773 Fax: (610) 448-1787
2. Device Name and Classification:
Trade Name: Classification Name: Classification Panel: CFR Section: Device Classification: Product Code:
OPDIMA Digital Mammographic X-ray System Mammographic X-Ray System Radiology 21 CFR §892.1710 Class II 90IZIL
3. Substantial Equivalence:
The OPDIMA is substantially equivalent to the following devices:
| Predicate Device Name | 510(k) Number | Clearance Date | Comparable Properties |
|---|---|---|---|
| OPDIMA Digital | |||
| Mammographic X-ray system | K003945 | 02/02/2001 | Hardware Control Software Image processing Intended use |
| OPDIMA Digital | |||
| Mammographic x-ray system | K071015 | 05/10/2007 | Control Software Image processing Intended use |
Siemens Medical Solutions USA, Inc. Special 510(k) OPDIMA UNIX to Windows
Page 15 of 55
Confidential
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4. Device Description:
OPDIMA is a Small Field Digital Mammography (SFDM) system. It is marketed as an option to the Siemens MAMMOMAT Novation X-ray examination system. It provides spot imaging for diagnosis and stereotactic biopsy. OPDIMA features a small (49 x 85 mm²) CCD detector that converts the X-ray attenuation into an electronic pattern. The electronic pattern is read out, processed, and displayed on a high resolution monitor. The images may be post processed, printed, or transferred via DICOM network for multiple purposes.
5. Intended Use of the Device:
The Siemens MAMMOMAT series with OPDIMA option is intended for use in small field mammographic X-ray imaging. Such small field imaging is used during stereotactic biopsy and diagnostic spot localization.
Technology Characteristics of the principle Device Compared to the 6. Predicate:
The OPDIMA functionality, the technology characteristics of the system, with the new Windows based workstation remain unchanged for the imaging characteristics. Graphical user interface and performance will improve to keep pace with the technology leap. The imaging area (49x85mm²) remains the same. The maximum resolution (high res mode 2048 x 3584 pixel) with 20 lp/mm and with 13 lp/mm (normal res mode 1024 x 1792 pixel) remains unchanged. Device dependent image processing remains unchanged. Each software module that is reused in the new Windows based workstation is converted to the Windows environment.
The OPDIMA software will run on the AWS of the MAMMOMAT Novation as an additional software module. The FFDM functionality will be disabled while the OPDIMA is in use.
7. General Safety and Effectiveness Concerns
Instructions for use are included within the device labeling and the information provided will enable the trained healthcare professional to operate the device in a safe and efficacious manner. Furthermore the operators are health care professionals familiar with and responsible for the X-ray examination to be performed.
8. Substantial Equivalence
It is the opinion of Siemens Medical Solutions USA, Inc. that the information provided establishes that the OPDIMA when used an option with the MAMMOMAT NovationPR Acquisition Workstation with Windows, is substantially equivalent to the commercially
2
available OPDIMA with UNIX workstation (K003945) and the OPDIMA with Windows workstation (K071015).
3
Image /page/3/Picture/0 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "U.S. Department of Health & Human Services". The symbol in the center consists of three stylized lines that resemble a person or a bird.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
SEP 2 5 2007
Ms. Kim Rendon Regulatory Technical Specialist Siemens Medical Solutions USA, Inc. 51 Valley Stream Pkwy, MS E50 MALVERN PA 19355
Re: K072392
Trade/Device Name: OPDIMA Regulation Number: 21 CFR 892.1710 Regulation Name: Mammographic x-ray system Regulatory Class: II Product*Code: IZL Dated: August 23, 2007 Received: August 27, 2007
Dear Ms. Rendon:
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 (Spocial 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.
Image /page/3/Picture/10 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the circle. The letters "FDA" are in the center of the circle. The word "Centennial" is at the bottom of the circle. There are stars around the circle.
relating and Promoting Publio Hoalth
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Page 2 -
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely vours,
Nancy Chogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
| 510(k) Number (if known): | K072393 |
|---|---|
| --------------------------- | --------- |
Device Name: OPDIMA
Indications for Use:
The Siemens MAMMOMAT series with OPDIMA option is intended for use in small field mammographic X-ray imaging (SFDM). Such small field imaging is used during stereotactic biopsy and diagnostic spot localization.
Prescription Use X OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of the CDRH, Office of Device Evaluation (ODE)
Aymuthwhy
(Division Sidn-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
Confidential