510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915541Substantially Equivalent

Spect Table, Model #056-760

Atomic Products Corp., Shirley NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915541 is the FDA 510(k) clearance record for SPECT TABLE, MODEL #056-760, a class I device, cleared for Atomic Products Corp. on under FDA product code IYZ (Bed, Scanning, Nuclear). FDA records list 10 510(k) clearances for Atomic Products Corp., from to . As of , FDA records show no recalls naming K915541.

Clearance record

Decision date
Received
(38 days to decision)
Product code
IYZ Bed, Scanning, Nuclear
Regulation
21 CFR 892.1350
Device class
Class I
Review panel
Radiology
Applicant
Atomic Products Corp. P.O. Drawer R, Shirley NY
510(k) summary
Summary
Third party review
No

Clearances, product code IYZ

Trailing 12 months

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

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