510(k) K811723

WHOLE BODY SCANNER by Cgr Medical Corp. — Product Code JAK

K811723 is an FDA 510(k) premarket notification submitted by Cgr Medical Corp. for the device "WHOLE BODY SCANNER". The FDA issued a decision of Substantially Equivalent on July 20, 1981. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Cgr Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1981
Date Received
June 18, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type