EMI Therapy Simulator
510(k) K771817
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK771817 | Date13 Jan 1978 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JAD
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.5900
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
The EMI Therapy Simulator is a System, Therapeutic, X-Ray device used in the field of Radiology. It is designed to simulate therapeutic X-ray procedures for training or testing purposes.
The device is supplied by Emi Therapy Systems, Inc. and was cleared via the FDA 510(k) pathway under K number K771817. It is classified as a Class II medical device with product code JAD and regulation number 892.5900, and is intended for use in radiological settings.
Other devices from Emi Therapy Systems, Inc.
Questions
AI-generated answers, 26 Sep 2026
What is the EMI Therapy Simulator used for?
The EMI Therapy Simulator is designed to simulate therapeutic X-ray procedures for training or testing purposes in radiological settings, allowing users to practice or evaluate procedures without patient exposure.
How is the EMI Therapy Simulator supplied and by whom?
The device is supplied by Emi Therapy Systems, Inc., the manufacturer, as a complete system for use in training or testing environments within radiology departments.
Is the EMI Therapy Simulator intended for single-use or reuse?
As a system designed to simulate therapeutic X-ray procedures, the EMI Therapy Simulator is intended for repeated use in training or testing scenarios, not for single-patient use, and is therefore reusable under appropriate maintenance and operational conditions.