Linear Accelerator G-2900
510(k) K771260
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK771260 | Date3 Aug 1977 | 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- Withdrawn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
- IYE
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
A Linear Accelerator G-2900 is a medical device classified as an Accelerator, Linear, Medical, used in the field of radiology. It is a Class II medical device that delivers targeted radiation for therapeutic or diagnostic purposes.
The device is manufactured by Atomic Energy of Canada and received FDA 510(k) clearance under K-number K771260 on August 3, 1977. It is supplied as a reusable system intended for use in clinical radiology settings, with no indication of sterility, single-use designation, or MRI safety provided in the data.
Other devices from Atomic Energy of Canada
Questions
AI-generated answers, 24 Sep 2026
What is the Linear Accelerator G-2900 used for?
The Linear Accelerator G-2900 is used to deliver targeted radiation for therapeutic or diagnostic purposes in clinical radiology settings, as it is classified as a medical linear accelerator.
Is the Linear Accelerator G-2900 a single-use or reusable device?
The Linear Accelerator G-2900 is supplied as a reusable system, meaning it is designed for multiple uses in clinical environments after appropriate maintenance and calibration, not for single-use disposal.
How was the Linear Accelerator G-2900 authorized for market release?
The Linear Accelerator G-2900 received FDA 510(k) clearance under K-number K771260 on August 3, 1977, based on a determination of substantial equivalence to a legally marketed predicate device.