510(k) K241495

Jazz Classic by Jazz Imaging — Product Code LLZ

K241495 is an FDA 510(k) premarket notification submitted by Jazz Imaging for the device "Jazz Classic". The FDA issued a decision of Substantially Equivalent on November 21, 2024. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Jazz Imaging has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2024
Date Received
May 28, 2024
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