510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K850330Substantially Equivalent

Angiotec Sc 1221 Scan Converter

Angiotec, Burlingame CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850330 is the FDA 510(k) clearance record for ANGIOTEC SC 1221 SCAN CONVERTER, a class II device, cleared for Angiotec on under FDA product code LMA (Digitizer, Image, Radiological). FDA records list one 510(k) clearance for Angiotec. As of , FDA records show no recalls naming K850330.

Clearance record

Decision date
Received
(92 days to decision)
Product code
LMA Digitizer, Image, Radiological
Regulation
21 CFR 892.2030
Device class
Class II
Review panel
Radiology
Applicant
Angiotec 384 Beach Rd., Burlingame CA
Third party review
No

Clearances, product code LMA

Trailing 12 months

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

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