510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K000987Substantially Equivalent

Vfss Imager, Model Sis-300

Lifecare Imaging Intl., Ltd., Lake In The Hills IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000987 is the FDA 510(k) clearance record for VFSS IMAGER, MODEL SIS-300, a class II device, cleared for Lifecare Imaging Intl., Ltd. on under FDA product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified). FDA records list one 510(k) clearance for Lifecare Imaging Intl., Ltd. As of , FDA records show no recalls naming K000987.

Clearance record

Decision date
Received
(66 days to decision)
Product code
JAA System, X-Ray, Fluoroscopic, Image-Intensified
Regulation
21 CFR 892.1650
Device class
Class II
Review panel
Radiology
Applicant
Lifecare Imaging Intl., Ltd. 8411 Pyott Rd., Lake In The Hills IL
510(k) summary
Statement
Third party review
No

Clearances, product code JAA

Trailing 12 months
1 clearance under product code JAA in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JAA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260