Hot Shot
510(k) K833233
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK833233 | Date28 Oct 1983 | 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- Withdrawn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
- IYO
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1560
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Hot Shot is a System, Imaging, Pulsed Echo, Ultrasonic device designed for diagnostic radiology. It employs ultrasound technology to generate real-time images of internal body structures, aiding in the assessment of organs, tissues, and potential abnormalities. Cleared under the Radiology advisory committee, this device falls under the Class II regulatory classification, ensuring compliance with stringent imaging standards.
This device is supplied as a standalone ultrasound system, intended for use in radiology departments and clinical settings. It is not described as single-use or reusable in the regulatory data, though typical ultrasound systems of this era were likely reusable. The system adheres to FDA 510(k) clearance under K-number K833233, granted in 1983, with no additional sterility or MRI safety specifications noted. Storage and handling instructions are not provided in the available data.