Gammacon Image Translation System
by Numa Corp.
510(k) K931376
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK931376 | Date28 Jul 1993 | 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- Withdrawn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 Gammacon Image Translation System is an emission computed tomography system intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient.
The device received FDA 510(k) clearance under K931376 on July 28, 1993, and is classified under product code LLZ. It was determined to be substantially equivalent to a predicate device following a traditional review by the Radiology advisory committee.
Other devices from Numa Corp.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Gammacon Image Translation System and how does it function in clinical settings?
The Gammacon Image Translation System is designed to detect gamma ray- and positron-emitting radionuclides within the body, then generate cross-sectional images through computer reconstruction of the collected data. It functions as an emission computed tomography system, allowing clinicians to visualize the location and distribution of radioactive tracers, which aids in diagnostic imaging for conditions like cancer, heart disease, or neurological disorders.
How is the Gammacon Image Translation System supplied, and is it intended for single-use or reusable applications?
The device is supplied as a complete emission computed tomography system, including signal analysis and display equipment, along with patient interfacing components. While the exact supply details (e.g., packaging) are not specified, the lack of mention of single-use materials or disposable parts suggests it is designed for reusable clinical applications, requiring proper cleaning and maintenance between uses. Always follow manufacturer guidelines for sterilization and reprocessing.
What regulatory pathway was followed for FDA clearance of the Gammacon Image Translation System, and what does this mean for its use?
The Gammacon Image Translation System received FDA clearance under a 510(k) traditional review (K931376) on July 28, 1993, following a determination of substantial equivalence to a predicate device. This means the FDA reviewed it through a formal advisory committee (Radiology) and concluded it met safety and effectiveness standards for its intended use as an emission computed tomography system. Clinicians can rely on this clearance as evidence of regulatory scrutiny, though ongoing compliance with FDA requirements remains necessary.
Is there any information about the storage requirements or environmental conditions for the Gammacon Image Translation System?
The provided data does not specify detailed storage requirements, such as temperature ranges or humidity controls. However, as a medical imaging device, it should be stored in a clean, dry environment protected from physical damage and electromagnetic interference. Follow the manufacturer’s instructions (Numa Corp.) for optimal performance, particularly if the system includes electronic or radiation-sensitive components.