510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K982498Substantially Equivalent

Diagnostic Ultrasound System

Volumetrics Medical Imaging, Inc., Durham NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982498 is the FDA 510(k) clearance record for DIAGNOSTIC ULTRASOUND SYSTEM, a class II device, cleared for Volumetrics Medical Imaging, Inc. on under FDA product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). FDA records list 2 510(k) clearances for Volumetrics Medical Imaging, Inc., from to . As of , FDA records show no recalls naming K982498.

Clearance record

Decision date
Received
(21 days to decision)
Product code
IYN System, Imaging, Pulsed Doppler, Ultrasonic
Regulation
21 CFR 892.1550
Device class
Class II
Review panel
Radiology
Applicant
Volumetrics Medical Imaging, Inc. 700 Main St., Durham NC
510(k) summary
Statement
Third party review
No

Clearances, product code IYN

Trailing 12 months
53 clearances under product code IYN in the twelve months to October 2026, May 2026 the highest month at 11.
Show the numbers
Monthly 510(k) clearances under FDA product code IYN, trailing twelve months
MonthClearances
November 20256
December 20256
January 20264
February 20261
March 20266
April 20263
May 202611
June 20263
July 20266
August 20263
September 20263
October 20261