IZG · System, X-Ray, Photofluorographic
Radiology · 21 CFR 892.1730 · Class 2
Overview
| Product Code | IZG |
|---|---|
| Device Name | System, X-Ray, Photofluorographic |
| Regulation | 21 CFR 892.1730 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
Identification
A photofluorographic x-ray system is a device that includes a fluoroscopic x-ray unit and a camera intended to be used to produce, then photograph, a fluoroscopic image of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Classification Rationale
Class II (special controls). A discography kit intended for use with a photofluorographic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Special Controls
*Classification.* Class II (special controls). A discography kit intended for use with a photofluorographic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K960082 | DISCOGRAPHY KIT | Spinal Specialties, Inc. | Mar 21, 1996 | SESE |
| K960146 | G.E. STERILE DISPOSABLE RADIOGRAPHIC CONTRAST TRAY | GE Medical Systems | Feb 27, 1996 | SESE |
| K913436 | PXI PNEUMATIC COMPRESSION PADDLE | Brotherston/Pxi | Nov 5, 1992 | SESE |
| K920393 | MU125M MOBILE X-RAY SYSTEM | Shimadzu Medical Systems | Apr 6, 1992 | SESE |
| K910503 | DISCOGRAPHY KIT | B. Braun of America, Inc. | Oct 7, 1991 | SESK |
| K903808 | AMSIS RDS, RADIOGRAPHIC DISCOGRAPHY KIT | Advanced Med/Surg, Inc. | Jan 22, 1991 | SESE |
| K892659 | ELECTRODELCA | Oldelft Corp. of America | Nov 21, 1989 | SESE |
Top Applicants
- Spinal Specialties, Inc. — 1 clearance
- Shimadzu Medical Systems — 1 clearance
- Oldelft Corp. of America — 1 clearance
- GE Medical Systems — 1 clearance
- Brotherston/Pxi — 1 clearance
