510(k) K873580

MHTI CT-SIM RADIATION THERAPY TREATMENT SIMULATOR by Medical High Technology International, Inc. — Product Code KPQ

K873580 is an FDA 510(k) premarket notification submitted by Medical High Technology International, Inc. for the device "MHTI CT-SIM RADIATION THERAPY TREATMENT SIMULATOR". The FDA issued a decision of Substantially Equivalent on Nov 2, 1987. The device falls under product code KPQ (System, Simulation, Radiation Therapy), a Class II device regulated under 21 CFR 892.5840.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 2, 1987
Date Received
Aug 27, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
System, Simulation, Radiation Therapy
Device Class
Class II
Regulation Number
892.5840
Review Panel
RA
Submission Type
510(k)

Source: FDA 510(k) database entry for K873580. Report a data issue: hello@regdatalab.com.