510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K771816Substantially Equivalent

Roche Axiscan 5

Roche Medical Electronics, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K771816 is the FDA 510(k) clearance record for ROCHE AXISCAN 5, a class II device, cleared for Roche Medical Electronics, Inc. on under FDA product code HEM (Imager, Ultrasonic Obstetric-Gynecologic). FDA records list 16 510(k) clearances for Roche Medical Electronics, Inc., from to . As of , FDA records show no recalls naming K771816.

Clearance record

Decision date
Received
(22 days to decision)
Product code
HEM Imager, Ultrasonic Obstetric-Gynecologic
Regulation
21 CFR 884.2225
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Roche Medical Electronics, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HEM

Trailing 12 months

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

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