510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912819Substantially Equivalent

Sc1150 Cw/pd

Pie Medical Equipment B.V., Maastricht, NL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912819 is the FDA 510(k) clearance record for SC1150 CW/PD, a class II device, cleared for Pie Medical Equipment B.V. on under FDA product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). FDA records list 8 510(k) clearances for Pie Medical Equipment B.V., from to . As of , FDA records show no recalls naming K912819.

Clearance record

Decision date
Received
(198 days to decision)
Product code
IYN System, Imaging, Pulsed Doppler, Ultrasonic
Regulation
21 CFR 892.1550
Device class
Class II
Review panel
Radiology
Applicant
Pie Medical Equipment B.V. Philipsweg 1, Maastricht, NL
510(k) summary
Statement
Third party review
No

Clearances, product code IYN

Trailing 12 months
52 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 20260