510(k) K233620

MIM - Centiloid Scaling by Mim Software, Inc. — Product Code LLZ

K233620 is an FDA 510(k) premarket notification submitted by Mim Software, Inc. for the device "MIM - Centiloid Scaling". The FDA issued a decision of Substantially Equivalent on May 20, 2024. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Mim Software, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2024
Date Received
November 13, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type