Cleared Traditional

K940442 - MPR-814
(FDA 510(k) Clearance)

K940442 · Xri, Inc. · Radiology device

Jun 1994

Decision

128d

Days

Class 1

Risk

K940442 is an FDA 510(k) clearance for the MPR-814. This device is classified as a Tube Mount, X-ray, Diagnostic (Class I - General Controls, product code IYB).

Submitted by Xri, Inc. (Tustin, US). The FDA issued a Cleared decision on June 9, 1994, 128 days after receiving the submission on February 1, 1994.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1770.

Submission Details

510(k) Number	K940442 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 01, 1994
Decision Date	June 09, 1994
Days to Decision	128 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement