FDI 2000 Ultrasonic Skin Scanner
by Fulmer Dyson Intl. 510(k)
Active
510(k) K902965
Overview
The FDI 2000 Ultrasonic Skin Scanner is a device designed for ultrasonic imaging of the skin. It is intended for use in radiology settings to visualize skin structures using ultrasound technology.
The device is supplied as a reusable system and was granted FDA 510(k) clearance under K902965 with product code IYO. It was determined to be substantially equivalent to a predicate device and cleared through the traditional review process by the Radiology advisory committee.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK902965 | Date26 Sep 1990 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- IYO
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1560
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the FDI 2000 Ultrasonic Skin Scanner used for?
The FDI 2000 Ultrasonic Skin Scanner is designed for ultrasonic imaging of the skin and is intended for use in radiology settings to visualize skin structures using ultrasound technology, as stated in its description.
Is the FDI 2000 Ultrasonic Skin Scanner reusable or single-use?
The device is supplied as a reusable system, meaning it is intended for multiple uses after appropriate cleaning and reprocessing, according to the provided specifications.
What regulatory clearance does the FDI 2000 Ultrasonic Skin Scanner have?
The FDI 2000 Ultrasonic Skin Scanner was granted FDA 510(k) clearance under K902965 with product code IYO, determined to be substantially equivalent to a predicate device through the traditional review process.