510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853734Substantially Equivalent

Apollo Densitometer

Astral Medical Systems, Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853734 is the FDA 510(k) clearance record for APOLLO DENSITOMETER, a class I device, cleared for Astral Medical Systems on under FDA product code JQT (Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica). FDA records list 4 510(k) clearances for Astral Medical Systems, from to . As of , FDA records show no recalls naming K853734.

Clearance record

Decision date
Received
(19 days to decision)
Product code
JQT Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
Regulation
21 CFR 862.2400
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Astral Medical Systems 2861 Pullman St., Santa Ana CA
Third party review
No

Clearances, product code JQT

Trailing 12 months

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

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