510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894992Substantially Equivalent

Quantum Qad Angiodynograph Ultrasound System

Quantum Medical Systems, Inc., Issaquah WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894992 is the FDA 510(k) clearance record for QUANTUM QAD ANGIODYNOGRAPH ULTRASOUND SYSTEM, a class II device, cleared for Quantum Medical Systems, Inc. on under FDA product code MAA (Monitor, Fetal Doppler Ultrasound). FDA records list 5 510(k) clearances for Quantum Medical Systems, Inc., from to . As of , FDA records show no recalls naming K894992.

Clearance record

Decision date
Received
(199 days to decision)
Product code
MAA Monitor, Fetal Doppler Ultrasound
Regulation
21 CFR 884.2660
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Quantum Medical Systems, Inc. 1040 12th Ave., Issaquah WA
Third party review
No

Clearances, product code MAA

Trailing 12 months

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

FDA records show no clearances under product code MAA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MAA, 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