510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K100849Substantially Equivalent

Sync-Rx System, Model As00010

Sync-Rx, Ltd., Lakewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100849 is the FDA 510(k) clearance record for SYNC-RX SYSTEM, MODEL AS00010, a class II device, cleared for Sync-Rx, Ltd. on under FDA product code IZI (System, X-Ray, Angiographic). FDA records list one 510(k) clearance for Sync-Rx, Ltd. As of , FDA records show no recalls naming K100849.

Clearance record

Decision date
Received
(56 days to decision)
Product code
IZI System, X-Ray, Angiographic
Regulation
21 CFR 892.1600
Device class
Class II
Review panel
Radiology
Applicant
Sync-Rx, Ltd. 555 Zang St., Suite 100, Lakewood CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IZI

Trailing 12 months
2 clearances under product code IZI in the twelve months to October 2026, May 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IZI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20262
June 20260
July 20260
August 20260
September 20260
October 20260