510(k) K772313

X-RAY CO-ORDINATOR by Rinn Corp. — Product Code IWY

K772313 is an FDA 510(k) premarket notification submitted by Rinn Corp. for the device "X-RAY CO-ORDINATOR". The FDA issued a decision of Substantially Equivalent on January 30, 1978. The device falls under product code IWY (Holder, Head, Radiographic), a Class I device regulated under 21 CFR 892.1920. Rinn Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1978
Date Received
December 12, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Head, Radiographic
Device Class
Class I
Regulation Number
892.1920
Review Panel
RA
Submission Type