510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K180162Substantially Equivalent

VivaScope System

Caliber Imaging & Diagnostics, Inc., Rochester NY / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K180162 is the FDA 510(k) clearance record for VivaScope System, a class II device, cleared for Caliber Imaging & Diagnostics, Inc. on under FDA product code PSN (Light Based Imaging). FDA's definition for product code PSN reads: "Emission and collection of light to create an image for medical purposes". FDA records list one 510(k) clearance for Caliber Imaging & Diagnostics, Inc. As of , FDA records show no recalls naming K180162.

Clearance record

Decision date
Received
(104 days to decision)
Product code
PSN Light Based Imaging
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Caliber Imaging & Diagnostics, Inc. 50 Methodist Hill Dr., Rochester NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PSN

Trailing 12 months

FDA records hold no clearances under product code PSN in the trailing twelve months.

FDA records show no clearances under product code PSN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PSN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260