Question 1

Who is the manufacturer of CARDIAC TRIAD NUCLEAR IMAGING SYSTEM?

Accepted Answer

Trionix Research Laboratory, Inc. filed the 510(k) submission for CARDIAC TRIAD NUCLEAR IMAGING SYSTEM (K920776).

Question 2

What is the FDA product code for CARDIAC TRIAD NUCLEAR IMAGING SYSTEM?

Accepted Answer

KPS. It is classified under 21 CFR 892.1200 as a Class 2 device in the Radiology panel.

Question 3

When was CARDIAC TRIAD NUCLEAR IMAGING SYSTEM cleared by the FDA?

Accepted Answer

Apr 27, 1992 (decision: SESE).

Question 4

What is the regulatory pathway for CARDIAC TRIAD NUCLEAR IMAGING SYSTEM?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like CARDIAC TRIAD NUCLEAR IMAGING SYSTEM?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K920776
Device Name	CARDIAC TRIAD NUCLEAR IMAGING SYSTEM
Applicant	Trionix Research Laboratory, Inc.
Product Code	KPS · Radiology
Decision Date	Apr 27, 1992
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1200
Device Class	Class 2

CARDIAC TRIAD NUCLEAR IMAGING SYSTEM

Device Facts

Regulatory Classification

Identification