Cleared Traditional

K012165 - OLDELFT THORASCAN MODEL NUMBER 180T
(FDA 510(k) Clearance)

K012165 · Nucletron Corp. · Radiology

Sep 2001

Decision

70d

Days

Class 2

Risk

K012165 is an FDA 510(k) clearance for the OLDELFT THORASCAN MODEL NUMBER 180T, a System, X-ray, Stationary (Class II — Special Controls, product code KPR), submitted by Nucletron Corp. (Columbia, US). The FDA issued a Cleared decision on September 19, 2001, 70 days after receiving the submission on July 11, 2001. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number	K012165 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 11, 2001
Decision Date	September 19, 2001
Days to Decision	70 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF