14X14 Multiformat Spot Filmer, No. 6650.400
510(k) K881589
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK881589 | Date18 Jul 1988 | 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- Withdrawn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, 25 Sep 2026
The 14x14 Multiformat Spot Filmer, No. 6650.400 is an electromechanical component of a fluoroscopic x-ray system. It is designed to position a radiographic film cassette to obtain radiographs during fluoroscopy procedures.
This device is classified as a Class II medical device under regulation number 892.1670. It received FDA 510(k) clearance under K881589 on July 18, 1988.
Other devices from Continental X-Ray Corp.
Questions
AI-generated answers, 25 Sep 2026
What is the primary function of the 14x14 Multiformat Spot Filmer?
This device serves as an electromechanical component within a fluoroscopic x-ray system. Its specific purpose is to position a radiographic film cassette, allowing clinicians to capture radiographs during fluoroscopy procedures.
What is the regulatory status of this spot filmer?
The 14x14 Multiformat Spot Filmer, No. 6650.400 is a Class II medical device that received FDA 510(k) clearance on July 18, 1988, under submission number K881589.
Under which medical specialty is this device categorized?
This device is categorized under the Radiology medical specialty. It is classified by the FDA under regulation number 892.1670, which pertains to spot-film devices used in diagnostic imaging.