510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912249Substantially Equivalent

Patient Dose Monitor

Theta Systems, Inc., Melbourne FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912249 is the FDA 510(k) clearance record for PATIENT DOSE MONITOR, a class II device, cleared for Theta Systems, Inc. on under FDA product code KPZ (Generator, High Voltage, X-Ray, Therapeutic). FDA records list 2 510(k) clearances for Theta Systems, Inc., from to . As of , FDA records show no recalls naming K912249.

Clearance record

Decision date
Received
(101 days to decision)
Product code
KPZ Generator, High Voltage, X-Ray, Therapeutic
Regulation
21 CFR 892.5900
Device class
Class II
Review panel
Radiology
Applicant
Theta Systems, Inc. 6425 Anderson Way, Melbourne FL
510(k) summary
Summary
Third party review
No

Clearances, product code KPZ

Trailing 12 months

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

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