Cleared Traditional

K034059 - SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE (FDA 510(k) Clearance)

K034059 · Sectra AB · Radiology device

Mar 2004

Decision

69d

Days

Class 2

Risk

K034059 is an FDA 510(k) clearance for the SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Sectra AB (Denton, US). The FDA issued a Cleared decision on March 9, 2004, 69 days after receiving the submission on December 31, 2003.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K034059 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 31, 2003
Decision Date	March 09, 2004
Days to Decision	69 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF