Cleared Traditional

STRATASYS FDM MEDMODELER SYSTEM

K971290 · Paladin Medical, Inc. · Radiology
Jun 1997
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K971290 is an FDA 510(k) clearance for the STRATASYS FDM MEDMODELER SYSTEM, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Paladin Medical, Inc. (Stillwater, US). The FDA issued a Cleared decision on June 20, 1997, 74 days after receiving the submission on April 7, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K971290 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 1997
Decision Date June 20, 1997
Days to Decision 74 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050