IYZ · Bed, Scanning, Nuclear
Radiology · 21 CFR 892.1350 · Class 1
Overview
| Product Code | IYZ |
|---|---|
| Device Name | Bed, Scanning, Nuclear |
| Regulation | 21 CFR 892.1350 |
| Device Class | Class 1 |
| Review Panel | Radiology |
Identification
A nuclear scanning bed is an adjustable bed intended to support a patient during a nuclear medicine procedure.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K920962 | MULTIPLE ACCESSORY TO GAMMA CAMERAS | Nu Age Products | Apr 17, 1992 | SESE |
| K915541 | SPECT TABLE, MODEL #056-760 | Atomic Products Corp. | Jan 17, 1992 | SESE |
| K911691 | XYZ CRANK IMAGING TABLE | Med-Tron Products, Inc. | Aug 9, 1991 | SESE |
| K912481 | ECT CARBON FIBER PALLET, MODIFICATION | Siemens Gammasonics, Inc. | Aug 2, 1991 | SESE |
| K912286 | CARDIAC SPECT PALLET | Siemens Gammasonics, Inc. | Aug 2, 1991 | SESE |
| K912181 | E-Z LIFT CRANK IMAGING TABLE | Med-Tron Products, Inc. | Jul 17, 1991 | SESE |
| K912135 | XY IMAGING TABLE | Med-Tron Products, Inc. | Jul 17, 1991 | SESE |
| K911564 | E-Z LIFT IMAGING TABLE WITH FOOT PUMP | Med-Tron Products, Inc. | Jul 15, 1991 | SESE |
| K911561 | XYZ IMAGING TABLE WITH FOOT PUMP | Med-Tron Products, Inc. | Jul 15, 1991 | SESE |
| K903901 | SCANNING COT | Med-Tron Products, Inc. | Sep 21, 1990 | SESE |
| K903767 | ECT (EMMISSION COMPUTED TOMOGRAPHY) CARBON FIB PAL | Siemens Gammasonics, Inc. | Sep 7, 1990 | SESE |
| K893826 | QRSYSTEMS H.D. NUCLEAR IMAGING TABLE | Qrsystems, Inc. | Aug 2, 1989 | SESE |
Top Applicants
- Med-Tron Products, Inc. — 6 clearances
- Siemens Gammasonics, Inc. — 3 clearances
- Qrsystems, Inc. — 1 clearance
- Nu Age Products — 1 clearance
- Atomic Products Corp. — 1 clearance
