510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K964288Substantially Equivalent

Call-Rad Pc Teleradiology

Pc Teleradiology, Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964288 is the FDA 510(k) clearance record for CALL-RAD PC TELERADIOLOGY, a class II device, cleared for Pc Teleradiology on under FDA product code LMA (Digitizer, Image, Radiological). FDA records list one 510(k) clearance for Pc Teleradiology. As of , FDA records show no recalls naming K964288.

Clearance record

Decision date
Received
(177 days to decision)
Product code
LMA Digitizer, Image, Radiological
Regulation
21 CFR 892.2030
Device class
Class II
Review panel
Radiology
Applicant
Pc Teleradiology 3519 E. Arcata Rd., Salt Lake City UT
510(k) summary
Statement
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