Digimamo D
by Vmi Tecnologias Ltda 510(k)
Active
510(k) K210151
Overview
The Digimamo D is a Full Field Digital X-Ray Mammographic System, designed for digital breast imaging. It produces high-resolution digital images of breast tissue, enabling enhanced detection and diagnosis of breast abnormalities such as calcifications, masses, and microcalcifications. This system is classified as a Class II medical device under FDA regulations, adhering to standards for mammographic imaging equipment.
The Digimamo D is intended for use in radiology departments within healthcare facilities, providing single-use or reusable components depending on the configuration. It operates under FDA clearance (510(k) K210151) and is regulated under the Radiology advisory committee. The system is supplied with multiple FEI numbers (e.g., 3001722928, 3009717300) and is designed for sterile or non-sterile use based on clinical protocol. Storage and handling follow standard mammographic imaging protocols to ensure image quality and patient safety.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK210151 | Date1 Mar 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- MUE
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1715
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Vmi Tecnologias Ltda
Questions
What is the Digimamo D used for in clinical settings?
The Digimamo D is a Full Field Digital X-Ray Mammographic System designed specifically for digital breast imaging. It produces high-resolution images of breast tissue to aid in the detection and diagnosis of breast abnormalities such as calcifications, masses, and microcalcifications. This system is intended for use in radiology departments within healthcare facilities to improve early detection and accurate assessment of breast conditions.
How is the Digimamo D supplied, and what are its key FEI numbers?
The Digimamo D is supplied with multiple FEI (Facility Equipment Identifier) numbers, including 3001722928, 3009717300, and others listed in the regulatory records. These identifiers help track and manage the device in clinical settings. The system can be configured with either single-use or reusable components, depending on the clinical protocol and facility requirements.
Is the Digimamo D sterile, and how should it be stored?
The Digimamo D can be used in either sterile or non-sterile configurations, depending on the clinical protocol and the specific components in use. For sterile applications, follow standard mammographic imaging protocols to ensure proper handling and storage. The device should be stored in a clean, dry environment, protected from physical damage and extreme temperatures, to maintain image quality and patient safety.
What regulatory approval does the Digimamo D hold, and how was it classified?
The Digimamo D holds FDA clearance under the 510(k) pathway, specifically with clearance number K210151. It is classified as a Class II medical device under FDA regulations, adhering to standards for mammographic imaging equipment. The device was reviewed by the Radiology Advisory Committee (RA) and determined to be substantially equivalent to predicate devices.
Are there different models or sizes available for the Digimamo D?
The Digimamo D is a single system model designed for full-field digital mammography, but it may include interchangeable components or configurations to accommodate different clinical needs. The system’s specifications and configurations are standardized for digital breast imaging, ensuring consistent performance across installations. For specific variations, refer to the manufacturer’s technical documentation or regulatory records.