X-Ray Frame Holder
by Great Eastern Lumber Co., Inc. 510(k)
Active
510(k) K780999
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK780999 | Date27 Jun 1978 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- IZL
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1720
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The X-Ray Frame Holder is a device used in radiology. It is a Class II X-ray system, substantially equivalent to other devices, with a product code of IZL and regulation number 892.1720.
The device is supplied by Great Eastern Lumber Co., Inc. and has been issued FDA 510(k) clearance, with the k number K780999. It is used in radiology and has a medical specialty description of Radiology.
Other devices from Great Eastern Lumber Co., Inc.
Questions
AI-generated answers, 6 Oct 2026
What is the X-Ray Frame Holder used for?
The X-Ray Frame Holder is used in radiology, specifically as a Class II X-ray system, substantially equivalent to other devices.
Is the X-Ray Frame Holder cleared by the FDA?
Yes, the X-Ray Frame Holder has been issued FDA 510(k) clearance with the k number K780999, indicating it has met the necessary regulatory requirements.
What type of device is the X-Ray Frame Holder classified as?
The X-Ray Frame Holder is classified as a Class II X-ray system with a product code of IZL and regulation number 892.1720.