Med-Seg, Model BTMS 1000
by Bartron Medical Imaging, Inc.
510(k) K092328
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK092328 | Date26 Jul 2010 | 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- Withdrawn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, 19 Sep 2026
The Med-Seg, Model BTMS 1000 is a software-based medical device classified as a segmentation system for medical imaging. It processes and analyzes digital images and data from multiple imaging modalities, including CT, MR, US, RF units, computed radiography, and secondary capture devices to assist in image segmentation and post-processing tasks.
This device is intended for use in radiology settings and operates as a standalone software solution. It is supplied as a non-sterile, reusable system with no specific MRI safety classification noted. The device received FDA 510(k) clearance under K092328 in 2010, confirming its regulatory compliance for commercial distribution in the United States.
Questions
AI-generated answers, 19 Sep 2026
What types of medical imaging data can the Med-Seg, Model BTMS 1000 process and analyze?
The Med-Seg, Model BTMS 1000 is designed to process and analyze digital images from multiple imaging modalities, including CT (computed tomography), MR (magnetic resonance), US (ultrasound), RF (radiofrequency) units, computed radiography systems, and secondary capture devices. This versatility allows it to assist in segmentation and post-processing tasks across a broad range of radiology applications.
Is the Med-Seg, Model BTMS 1000 a standalone software solution, and how is it supplied?
Yes, the Med-Seg, Model BTMS 1000 operates as a standalone software-based medical device, meaning it does not require physical integration with imaging hardware beyond receiving digital data inputs. It is supplied as a non-sterile, reusable system, which means it can be used repeatedly in radiology settings without requiring single-use disposal.
What regulatory clearance does the Med-Seg, Model BTMS 1000 hold, and how does this affect its use in the U.S.?
The Med-Seg, Model BTMS 1000 received FDA 510(k) clearance under the reference number K092328, confirming it is legally marketed and distributed in the United States. This clearance indicates the device was determined to be substantially equivalent to a legally marketed predicate device, ensuring compliance with FDA regulations for commercial use in radiology settings.
Does the Med-Seg, Model BTMS 1000 have any specific safety classification for MRI environments?
The device documentation does not specify any particular MRI safety classification for the Med-Seg, Model BTMS 1000. Since it is a software-based system, its safety in MRI environments would depend on the hardware it is installed on, and users should verify compatibility with their specific MRI equipment and follow manufacturer guidelines to ensure safe operation.