21 CFR 892.1310 — System, Tomographic, Nuclear

Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1310

Identification

A nuclear tomography system is a device intended to detect nuclear radiation in the body and produce images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of devices may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
JWMSystem, Tomographic, Nuclear2173rd Party
Innolitics

Panel 1

/
Sort by
Ready

Predicate graph will load when search results are available.

Embedding visualization will load when search results are available.

PDF viewer will load when search results are available.

Loading panels...

Select an item from Submissions

Click any panel, subpart, regulation, product code, or device to see details here.

Section Matches

Results will appear here.

Product Code Matches

Results will appear here.

Special Control Matches

Results will appear here.

Loading collections...