510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K241770Substantially Equivalent

Prostate MR AI (VA10A)

Siemens Healthcare GmbH, Erlanger, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K241770 is the FDA 510(k) clearance record for Prostate MR AI (VA10A), a class II device, cleared for Siemens Healthcare GmbH on under FDA product code QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer). FDA's definition for product code QDQ reads: "A radiological computer assisted detection and diagnostic software for suspected lesions is an image processing device intended to aid in the detection, localization, and characterization of lesions suspicious for cancer on acquired...". FDA records list 32 510(k) clearances for Siemens Healthcare GmbH, from to . As of , FDA records show no recalls naming K241770.

Clearance record

Decision date
Received
(258 days to decision)
Product code
QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Regulation
21 CFR 892.2090
Device class
Class II
Review panel
Radiology
Applicant
Siemens Healthcare GmbH Henkestr. 127, Erlanger, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QDQ

Trailing 12 months
10 clearances under product code QDQ in the twelve months to October 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code QDQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20261
April 20262
May 20260
June 20262
July 20261
August 20262
September 20261
October 20260