510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K923180Substantially Equivalent

Specturn, Model Ttk-128

Harpell Assoc., Inc., Oakville, Ontario, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923180 is the FDA 510(k) clearance record for SPECTURN, MODEL TTK-128, a class I device, cleared for Harpell Assoc., Inc. on under FDA product code IYX (Camera, Scintillation (Gamma)). FDA records list one 510(k) clearance for Harpell Assoc., Inc. As of , FDA records show no recalls naming K923180.

Clearance record

Decision date
Received
(391 days to decision)
Product code
IYX Camera, Scintillation (Gamma)
Regulation
21 CFR 892.1100
Device class
Class I
Review panel
Radiology
Applicant
Harpell Assoc., Inc. 1272 Speers Rd., Unit 2, Oakville, Ontario, CA
510(k) summary
Statement
Third party review
No

Clearances, product code IYX

Trailing 12 months

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

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