Mammo Workstation
by Image Diagnost International GmbH
510(k) K081630
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK081630 | Date29 Jul 2008 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Mammo Workstation is a diagnostic imaging device classified as a Mammography Workstation (Product Code: LLZ), designed for the primary diagnostic review of mammographic images. It facilitates radiologists in evaluating multi-modality softcopy images through flexible and interactive manipulation, supporting both screening and diagnostic mammography workflows. The system integrates digital imaging capabilities to enhance visualization and assessment of breast tissue.
This device is intended for use in radiology departments and is supplied as a reusable, non-sterile medical instrument. It is cleared under FDA 510(k) (K081630) as substantially equivalent to a predicate device, with regulatory oversight by the Radiology (RA) Advisory Committee. The workstation requires proper calibration and maintenance in controlled environments to ensure accurate image interpretation. No MRI safety classification or single-use designation is specified in the regulatory filing.
Other devices from Image Diagnost International GmbH
Questions
AI-generated answers, 1 Oct 2026
What is the Mammo Workstation designed for?
The Mammo Workstation is specifically designed for the primary diagnostic review of mammographic images in radiology departments. It allows radiologists to evaluate multi-modality softcopy images with flexible and interactive tools, improving visualization and assessment of breast tissue for both screening and diagnostic mammography workflows.
Is the Mammo Workstation reusable or single-use?
The Mammo Workstation is supplied as a reusable, non-sterile medical instrument. It is intended for use in clinical settings where proper calibration and maintenance are maintained to ensure accurate and reliable image interpretation.
What regulatory approval does the Mammo Workstation hold?
The Mammo Workstation is cleared under FDA 510(k) (K081630) as substantially equivalent to a predicate device. The regulatory filing was reviewed by the Radiology (RA) Advisory Committee, and the device falls under Product Code LLZ for Mammography Workstations.
Does the Mammo Workstation require special storage or environmental conditions?
The Mammo Workstation is intended for use in controlled environments where proper calibration and maintenance can be performed. While no specific sterility requirements are stated, it should be stored in a clean, dry location to prevent dust or debris from affecting image quality or device functionality.
Can this workstation be used with other imaging modalities?
Yes, the Mammo Workstation is designed to support the evaluation of multi-modality softcopy images. This means it can integrate digital imaging capabilities beyond mammography, aiding radiologists in assessing breast tissue across different imaging techniques for comprehensive diagnostic review.