510(k) K915541

SPECT TABLE, MODEL #056-760 by Atomic Products Corp. — Product Code IYZ

K915541 is an FDA 510(k) premarket notification submitted by Atomic Products Corp. for the device "SPECT TABLE, MODEL #056-760". The FDA issued a decision of Substantially Equivalent on January 17, 1992. The device falls under product code IYZ (Bed, Scanning, Nuclear), a Class I device regulated under 21 CFR 892.1350. Atomic Products Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1992
Date Received
December 10, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Scanning, Nuclear
Device Class
Class I
Regulation Number
892.1350
Review Panel
RA
Submission Type