510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN100016Unknown

Prostate Mechanical Imager

Artann Laboratories, Inc., Washington D.C. DC / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN100016 is the FDA 510(k) clearance record for PROSTATE MECHANICAL IMAGER, a class II device, cleared for Artann Laboratories, Inc. on under FDA product code OQT (Prostate Lesion, Documentation, System). FDA's definition for product code OQT reads: "Produces an elasticity image of the prostate to document prostate abnormalities that were previously identified by digital rectal examination". FDA records list one 510(k) clearance for Artann Laboratories, Inc. As of , FDA records show no recalls naming DEN100016.

Clearance record

Decision date
Received
(707 days to decision)
Product code
OQT Prostate Lesion, Documentation, System
Regulation
21 CFR 876.2050
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Artann Laboratories, Inc. 555 13th St., NW, Washington D.C. DC
Third party review
No

Clearances, product code OQT

Trailing 12 months

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

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