510(k) K811230

X-CELL X-RAY #'S P-75W/P-75M by X-Cel X-Ray Corp. — Product Code KPR

K811230 is an FDA 510(k) premarket notification submitted by X-Cel X-Ray Corp. for the device "X-CELL X-RAY #'S P-75W/P-75M". The FDA issued a decision of Substantially Equivalent on June 23, 1981. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. X-Cel X-Ray Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1981
Date Received
May 4, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type