Film Digitizer Model 2908 Mammo Pro
by Array Corp. Japan(FDA 510(k) applicant) 510(k)
510(k) K063424 Product code LMA
Overview
The Film Digitizer Model 2908 Mammo Pro is a radiological image digitizer designed to convert analog mammography film into digital images. It falls under the classification of an image digitizer, facilitating the transition from film-based to digital radiology workflows for enhanced storage, retrieval, and review of mammographic studies.
This device is intended for use in radiology settings and operates by scanning physical mammography film to produce digital output. Supplied as a reusable Class II device, it requires appropriate handling and maintenance per manufacturer guidelines. The Model 2908 Mammo Pro holds FDA 510(k) clearance under K-number K063424, with a product code of LMA, and was determined substantially equivalent in 2006.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK063424 | Date21 Dec 2006 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Film Digitzer, Model 2908 Mammo Pro
- 510(k) Number
- FDA Product Code
- LMA
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2030
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Array Corp.
Questions
What is the primary purpose of the Film Digitizer Model 2908 Mammo Pro in a clinical setting?
The Film Digitizer Model 2908 Mammo Pro is designed to convert analog mammography film into digital images, enabling radiology departments to transition from film-based to digital workflows. This conversion improves storage efficiency, retrieval speed, and the ability to review mammographic studies more effectively, which is particularly useful for long-term patient records and diagnostic accuracy.
Is the Film Digitizer Model 2908 Mammo Pro a single-use or reusable device, and what does this mean for maintenance?
The Film Digitizer Model 2908 Mammo Pro is a reusable Class II device, meaning it is built for repeated use in radiology settings. This requires adherence to manufacturer guidelines for proper handling, cleaning, and maintenance to ensure consistent performance and longevity of the device.
How was the regulatory approval process for the Film Digitizer Model 2908 Mammo Pro determined, and what does this mean for its use?
The device received FDA 510(k) clearance under K-number K063424, with a determination of substantial equivalence to a predicate device. This means the FDA evaluated it against an existing, legally marketed device and found it to be as safe and effective, allowing it to enter the market under the product code LMA for radiological image digitizers. The clearance was granted in 2006.
What type of facility or department would benefit most from using the Film Digitizer Model 2908 Mammo Pro?
The Film Digitizer Model 2908 Mammo Pro is specifically intended for radiology settings, particularly those handling mammography film. Facilities transitioning from analog to digital workflows, or those needing to digitize existing film archives, would benefit most from this device to streamline workflows and improve diagnostic efficiency.
What does the product code LMA indicate about the Film Digitizer Model 2908 Mammo Pro’s regulatory classification?
The product code LMA (Laser Mammography) assigned to the Film Digitizer Model 2908 Mammo Pro categorizes it under radiological image digitizers used for mammography. This classification helps regulatory bodies and healthcare providers identify its intended use within the broader context of medical imaging devices, ensuring proper compliance and application in clinical settings.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K063424