Cleared Traditional

K932356 - NOVA XM2
(FDA 510(k) Clearance)

K932356 · Dynarad Corp. · Radiology

Feb 1995

Decision

636d

Days

Class 2

Risk

K932356 is an FDA 510(k) clearance for the NOVA XM2. This device is classified as a System, X-ray, Mammographic (Class II — Special Controls, product code IZH).

Submitted by Dynarad Corp. (Deer Park, US). The FDA issued a Cleared decision on February 8, 1995, 636 days after receiving the submission on May 13, 1993.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1710.

Submission Details

510(k) Number	K932356 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 13, 1993
Decision Date	February 08, 1995
Days to Decision	636 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement