Spot-Film Device 8835
510(k) K842184
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK842184 | Date17 Jul 1984 | 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- Withdrawn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
- IXL
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1670
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Spot-Film Device 8835 is a Class 2 medical device used in radiology. It is a spot-film device, which is substantially equivalent to other devices in its class. The device is manufactured by General Electric Co.
The device is supplied with an FDA 510(k) clearance, K842184, and is regulated under the product code IXL. It is intended for use in radiology and has a device class of 2. The device has been cleared by the FDA since July 17, 1984.
Other devices from General Electric Co.
Questions
AI-generated answers, 22 Sep 2026
What is the Spot-Film Device 8835 used for?
The Spot-Film Device 8835 is used in radiology, and its intended use is substantially equivalent to other devices in its class.
Is the Spot-Film Device 8835 supplied sterile?
The device data does not specify if the Spot-Film Device 8835 is supplied sterile, but it is regulated under the product code IXL.
What is the regulatory status of the Spot-Film Device 8835?
The Spot-Film Device 8835 has been cleared by the FDA since July 17, 1984, with a 510(k) clearance number K842184.
What is the device class of the Spot-Film Device 8835?
The Spot-Film Device 8835 is a Class 2 medical device.