Gamma 600T
by Strichman Medical Equipment, Inc.
510(k) K923736
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK923736 | Date16 Oct 1992 | 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- Withdrawn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
- KPS
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1200
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Gamma 600T is a System, Tomography, Computed, Emission device, specifically designed for Single Photon Emission Computed Tomography (SPECT). It performs functional imaging by detecting gamma rays emitted from radiotracers within the body, enabling visualization of metabolic processes and blood flow in organs such as the brain, heart, and bones. This imaging modality is commonly used in nuclear medicine for diagnostic purposes, including the assessment of cardiac viability, brain perfusion, and oncological evaluations.
The Gamma 600T is intended for use in clinical radiology settings, where it is operated by trained nuclear medicine technologists or physicians. Supplied as a reusable medical device, it requires proper calibration, maintenance, and adherence to radiation safety protocols. The system is classified under FDA device class II and has received FDA 510(k) clearance under the traditional review pathway, with a decision date of October 16, 1992. No specific sterility or MRI safety information is provided in the available data, but standard radiation shielding and operational precautions must be followed during use.
Other devices from Strichman Medical Equipment, Inc.
Questions
AI-generated answers, 19 Sep 2026
What clinical applications is the Gamma 600T primarily used for in nuclear medicine imaging?
The Gamma 600T is designed for Single Photon Emission Computed Tomography (SPECT), which visualizes metabolic processes and blood flow in organs like the brain, heart, and bones. It is commonly used for assessing cardiac viability, evaluating brain perfusion, and conducting oncological evaluations, such as tumor detection and monitoring.
Is the Gamma 600T a single-use or reusable device, and what maintenance considerations should be taken into account?
The Gamma 600T is a reusable medical device, meaning it is intended for repeated use in clinical settings. Since it is not single-use, proper calibration, regular maintenance, and adherence to radiation safety protocols are essential to ensure accurate imaging and operator safety. No sterility information is provided, so cleaning and servicing procedures must follow manufacturer guidelines.
How is the Gamma 600T regulated in the United States, and what does its FDA clearance status indicate?
The Gamma 600T received FDA 510(k) clearance under the traditional review pathway, classified as a Class II device. This clearance indicates that the device is considered substantially equivalent to a legally marketed predicate device, meaning it meets the same performance standards and safety requirements. The clearance was granted on October 16, 1992, under the Radiology advisory committee.
Who is responsible for operating the Gamma 600T, and what training or expertise is required?
The Gamma 600T is intended for use in clinical radiology settings by trained nuclear medicine technologists or physicians. Operation requires familiarity with SPECT imaging, radiation safety protocols, and adherence to calibration and maintenance procedures to ensure accurate diagnostic results.
Are there any special storage or handling requirements for the Gamma 600T beyond standard radiation safety precautions?
While the provided data does not specify unique storage requirements beyond standard radiation safety measures, the Gamma 600T must be stored in a secure, controlled environment to prevent unauthorized access and ensure proper functionality. Radiation shielding and operational precautions must always be followed during use, storage, and transport.