510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K080581Substantially Equivalent

Vb Image Viewer

Olympus Medical Systems Corp., Center Valley PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080581 is the FDA 510(k) clearance record for VB IMAGE VIEWER, a class II device, cleared for Olympus Medical Systems Corporation on under FDA product code JAK (System, X-Ray, Tomography, Computed). FDA records list 186 510(k) clearances for Olympus Medical Systems Corporation, from to . As of , FDA records show no recalls naming K080581.

Clearance record

Decision date
Received
(227 days to decision)
Product code
JAK System, X-Ray, Tomography, Computed
Regulation
21 CFR 892.1750
Device class
Class II
Review panel
Radiology
Applicant
Olympus Medical Systems Corporation 3500 Corporate Pkwy., Center Valley PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JAK

Trailing 12 months
21 clearances under product code JAK in the twelve months to November 2026, March 2026 the highest month at 10.
Show the numbers
Monthly 510(k) clearances under FDA product code JAK, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 202610
April 20260
May 20261
June 20262
July 20262
August 20260
September 20264
October 20261
November 20260