510(k) K953724

CRONEX RADIATION THERAPY CASSETTE by E.I. Dupont DE Nemours & Co., Inc. — Product Code IXA

K953724 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "CRONEX RADIATION THERAPY CASSETTE". The FDA issued a decision of Substantially Equivalent on September 6, 1995. The device falls under product code IXA (Cassette, Radiographic Film), a Class II device regulated under 21 CFR 892.1850. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1995
Date Received
August 10, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cassette, Radiographic Film
Device Class
Class II
Regulation Number
892.1850
Review Panel
RA
Submission Type