X-POSURE System Version 2 MAMMO
by Pronosco A/S
510(k) K003656
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK003656 | Date15 Dec 2000 | 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- Withdrawn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
- KGI
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1170
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The X-POSURE System Version 2 MAMMO is a Densitometer, Bone, designed to measure bone density and mineral content using x-ray or gamma ray transmission through bone and adjacent tissues. It incorporates signal analysis and display equipment, patient positioning supports, and associated components as defined by regulatory classification 892.1170. This device is intended for radiologic assessment in clinical settings to evaluate skeletal integrity and diagnose conditions such as osteoporosis.
This system is supplied as a reusable medical device and is classified under FDA regulation 892.1170 as a Class II device, with clearance granted under a Special 510(k) pathway (K003656). It is intended for use in radiology departments and requires proper calibration and maintenance per manufacturer guidelines. The device is not single-use and must be handled in accordance with standard radiologic safety protocols, including MRI safety considerations where applicable. Storage and handling follow regulatory and facility-specific protocols to ensure accuracy and reliability.
Other devices from Pronosco A/S
Questions
AI-generated answers, 20 Sep 2026
What clinical conditions is the X-POSURE System Version 2 MAMMO primarily used to diagnose or assess in patients?
The X-POSURE System Version 2 MAMMO is designed to evaluate skeletal integrity and diagnose conditions such as osteoporosis by measuring bone density and mineral content through x-ray or gamma ray transmission. It provides radiologic assessment to help clinicians monitor bone health and identify potential fragility or metabolic bone disorders.
Is the X-POSURE System Version 2 MAMMO a single-use device, or is it intended for repeated use in a clinical setting?
The X-POSURE System Version 2 MAMMO is explicitly classified as a reusable medical device. It is not intended for single-use and must be maintained, calibrated, and handled according to standard radiologic safety protocols to ensure accuracy and reliability over multiple patient assessments.
What types of environments or departments is this device intended for, and are there any special handling considerations?
This device is intended for use in radiology departments and requires adherence to standard radiologic safety protocols. Since it involves x-ray or gamma ray transmission, it must be operated in compliance with facility-specific guidelines, including MRI safety considerations where applicable. Proper calibration and maintenance per manufacturer instructions are also mandatory.
How is the X-POSURE System Version 2 MAMMO supplied, and does it include any additional components beyond the densitometer itself?
The system is supplied as a complete reusable device that includes not only the densitometer but also signal analysis and display equipment, patient positioning supports, and associated components—all essential for accurate bone density measurements. These components are integrated as defined under FDA classification 892.1170.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use in clinical practice?
The X-POSURE System Version 2 MAMMO received FDA clearance under a Special 510(k) pathway (K003656), meaning it was determined to be substantially equivalent to a legally marketed predicate device. This clearance confirms its compliance with FDA standards for bone densitometers (Class II) and ensures it meets radiologic safety and performance requirements for clinical use in assessing skeletal integrity.