Cleared Traditional

K973848 - IBU, INTEGRATED BRACHY THERAPY UNIT
(FDA 510(k) Clearance)

K973848 · Nucletron Corp. · Radiology

Jan 1998

Decision

106d

Days

Class 2

Risk

K973848 is an FDA 510(k) clearance for the IBU, INTEGRATED BRACHY THERAPY UNIT, a System, Simulation, Radiation Therapy (Class II — Special Controls, product code KPQ), submitted by Nucletron Corp. (Columbia, US). The FDA issued a Cleared decision on January 22, 1998, 106 days after receiving the submission on October 8, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5840.

Submission Details

510(k) Number	K973848 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 08, 1997
Decision Date	January 22, 1998
Days to Decision	106 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF