Product Code: IYZ FDA class 1 21 CFR 892.1350

Bed, Scanning, Nuclear

Radiology

A nuclear scanning bed is a patient support table designed for use with nuclear medicine imaging systems, positioning and transporting the patient through the detector field during whole-body or regional scintigraphic scanning. It is classified as FDA Class 1, reflecting the lowest level of regulatory oversight, with only general controls required. The product code is IYZ, regulated under 21 CFR 892.1350, within the Radiology medical specialty. No special flags apply to this device.

510(k)s
12
FEI Numbers
3
Registration Numbers
3
Unique Applicants
5
Years Active
3

Research product code IYZ in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Basic Information

Product Code
IYZ
Device Class
FDA class 1
Regulation Number
892.1350
Medical Specialty
Radiology
Review Panel
RA
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

Loading...

Related 510(k) Clearances

This FDA classification is associated with 12 510(k) clearances via K numbers.

K Number Device Name
K920962 MULTIPLE ACCESSORY TO GAMMA CAMERAS
K915541 SPECT TABLE, MODEL #056-760
K911691 XYZ CRANK IMAGING TABLE
K912481 ECT CARBON FIBER PALLET, MODIFICATION
K912286 CARDIAC SPECT PALLET
K912181 E-Z LIFT CRANK IMAGING TABLE
K912135 XY IMAGING TABLE
K911564 E-Z LIFT IMAGING TABLE WITH FOOT PUMP
K911561 XYZ IMAGING TABLE WITH FOOT PUMP
K903901 SCANNING COT
K903767 ECT (EMMISSION COMPUTED TOMOGRAPHY) CARBON FIB PAL
K893826 QRSYSTEMS H.D. NUCLEAR IMAGING TABLE

FEI Numbers

This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.