510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K974423Substantially Equivalent

Ultra-Vision Mammography Detail, Ultra-Vision Mammography Fast Detail

Sterling Diagnostic Imaging, Inc., Greenville SC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974423 is the FDA 510(k) clearance record for ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL, a class I device, cleared for Sterling Diagnostic Imaging, Inc. on under FDA product code EAM (Screen, Intensifying, Radiographic). FDA records list 7 510(k) clearances for Sterling Diagnostic Imaging, Inc., from to . As of , FDA records show no recalls naming K974423.

Clearance record

Decision date
Received
(28 days to decision)
Product code
EAM Screen, Intensifying, Radiographic
Regulation
21 CFR 892.1960
Device class
Class I
Review panel
Radiology
Applicant
Sterling Diagnostic Imaging, Inc. P.O. Box 19048, Greenville SC
510(k) summary
Summary
Third party review
No

Clearances, product code EAM

Trailing 12 months

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

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