510(k) K883317

DCD-1 (DIGITAL CONTOUR DETECT-RADIAT THERAPY) SYST by S & S X-Ray Products, Inc. — Product Code IXI

K883317 is an FDA 510(k) premarket notification submitted by S & S X-Ray Products, Inc. for the device "DCD-1 (DIGITAL CONTOUR DETECT-RADIAT THERAPY) SYST". The FDA issued a decision of Substantially Equivalent on Apr 26, 1989. The device falls under product code IXI (Block, Beam-Shaping, Radiation Therapy), a Class II device regulated under 21 CFR 892.5710. S & S X-Ray Products, Inc. has 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 26, 1989
Date Received
Aug 5, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Block, Beam-Shaping, Radiation Therapy
Device Class
Class II
Regulation Number
892.5710
Review Panel
RA
Submission Type
510(k)

Source: FDA 510(k) database entry for K883317. Report a data issue: hello@regdatalab.com.