Cleared Traditional

K920962 - MULTIPLE ACCESSORY TO GAMMA CAMERAS
(FDA 510(k) Clearance)

K920962 · Nu Age Products · Radiology device

Apr 1992

Decision

74d

Days

Class 1

Risk

K920962 is an FDA 510(k) clearance for the MULTIPLE ACCESSORY TO GAMMA CAMERAS. This device is classified as a Bed, Scanning, Nuclear (Class I - General Controls, product code IYZ).

Submitted by Nu Age Products (Palmdale, US). The FDA issued a Cleared decision on April 17, 1992, 74 days after receiving the submission on February 3, 1992.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1350.

Submission Details

510(k) Number	K920962 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 03, 1992
Decision Date	April 17, 1992
Days to Decision	74 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF