510(k) K915156

I-125 SEEDS CODE: 6702 by Medi-Physics Inc. Dba Nycomed Amersham Imaging — Product Code KXK

K915156 is an FDA 510(k) premarket notification submitted by Medi-Physics Inc. Dba Nycomed Amersham Imaging for the device "I-125 SEEDS CODE: 6702". The FDA issued a decision of Substantially Equivalent on Jan 6, 1992. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. Medi-Physics Inc. Dba Nycomed Amersham Imaging has 8 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 6, 1992
Date Received
Nov 14, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Source, Brachytherapy, Radionuclide
Device Class
Class II
Regulation Number
892.5730
Review Panel
RA
Submission Type
510(k)

Source: FDA 510(k) database entry for K915156. Report a data issue: hello@regdatalab.com.