(30 days)
Not Found
No
The summary describes standard digital imaging processing and does not mention AI, ML, or related concepts.
No
The device is described as an X-ray imaging system for diagnostic purposes (spot localization and biopsy guidance), not for treating a disease or condition.
Yes
The device description explicitly states, "It provides spot imaging for diagnosis and stereo tactic biopsy." Additionally, the "Intended Use / Indications for Use" mentions "diagnostic spot localization," indicating its use in identifying and characterizing medical conditions.
No
The device description explicitly mentions hardware components like a CCD detector and a high-resolution monitor, indicating it is not software-only.
Based on the provided information, 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 Siemens MAMMOMAT series with OPDIMA option is an X-ray imaging system. It uses X-rays to create images of the breast for diagnostic and biopsy purposes. This is an in vivo (within the living body) imaging technique, not an in vitro test.
- Intended Use: The intended use clearly states "small field mammographic X-ray imaging" for "stereo tactic biopsy and diagnostic spot localization." This involves imaging the breast directly, not analyzing samples taken from the body.
- Device Description: The description details an X-ray system with a detector that converts X-ray attenuation into an electronic pattern for display. This aligns with an imaging device, not an IVD.
Therefore, the Siemens MAMMOMAT series with OPDIMA option falls under the category of a medical imaging device, not an in vitro diagnostic device.
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. Such small field imaging is used during stereo tactic biopsy and diagnostic spot localization.
Product codes
90IZL, IZH
Device Description
OPDIMA is a Small Field Digital Mammography (SFDM) system. It is marketed as an option to the Siemens MAMMOMAT series X-ray examination systems. It provides spot imaging for diagnosis and stereo tactic 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 at 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
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 (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
K07/015
April 4, 2007
MAY 1 0 2007
Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355
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.
Contact Person: 1.
Ms. Kimberly 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 90IZL
3. Substantial Equivalence:
The OPDIMA is substantially equivalent to the following device:
| 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 |
1
4. Device Description:
OPDIMA is a Small Field Digital Mammography (SFDM) system. It is marketed as an option to the Siemens MAMMOMAT series X-ray examination systems. It provides spot imaging for diagnosis and stereo tactic 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 at 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 stereo tactic biopsy and diagnostic spot localization.
6. Technology Characteristics of the principle Device Compared to the Predicate:
The OPDIMA functionality and technological characteristics of the system, with the new Windows based workstation imaging characteristics, remain the same. Graphical user interface and performance will be improved 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 1p/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.
7. General Satety 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 effective manner. Furthermore, the operators are health care professionals familiar with and responsible for the X-ray examination to be performed.
Substantial Equivalence 8.
In the opinion of Siemens Medical Solutions USA, Inc., the information provided establishes that OPDIMA with Windows based workstation is substantially equivalent to the commercially available OPDIMA with UNIX workstation.
2
Image /page/2/Picture/0 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem in the center, which consists of three stylized lines curving upwards and to the right, resembling a stylized human form. Encircling the emblem is the text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAY 1 0 2007
Ms. Kim Rendon Technical Specialist, Regulatory Affairs Siemens Medical Solutions USA, Inc. 51 Valley Stream Pkwy, MS E50 MALVERN PA 19355
Re: K071015
Trade/Device Name: MAMMOMAT Series with OPDIMA Option Regulation Number: 21 CFR 892.1710 Regulation Name: Mammographic x-ray system Regulatory Class: II Product Code: IZH Dated: April 4, 2007 Received: April 10, 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 (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.
Image /page/2/Picture/10 description: The image is a circular seal with the letters "PA" in the center. Above the letters, the numbers "1906-2006" are printed. Below the letters, the word "Centennial" is printed in a cursive font. There are three stars below the word "Centennial". The seal is surrounded by a dotted border.
Protecting and Promoting Public Health
3
Page 2 -
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r reast be advised that I Dri- issualise systems of the complies with other requirements of the Act that I Dri hes made a and regulations administered by other Federal agencies. You must of any i callated and regulanents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY at 807), labeling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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) This letter will anow you'ts bogin mains of substantial equivalence of your device to a legally premarket notification. The PDA intoning or easing of early 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 If you desire specific acrree for your as a f 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" Also, prease note the regulation other general information on your responsibilities under (21CFN art 607.77). " Four may octain other 3
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 yours,
Nancy C. hogdon
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
510(k) Number (if known): K071015
Device Name: OPDIMA
Indications for Use:
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 stereo tactic biopsy and diagnostic spot localization.
Prescription Use V 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)
Nancy C. Broadron
(Division Sign-Off)
(Division Sign-Off)/ Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number 101
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
CONFIDENTIAL