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
K253023Substantially Equivalent

BIOGRAPH One

Siemens Healthineers AG, Forchheim, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253023 is the FDA 510(k) clearance record for BIOGRAPH One, a class II device, cleared for Siemens Healthineers AG on under FDA product code OUO (Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance). FDA's definition for product code OUO reads: "Imager that generates both both magnetic resonance (mr) and positron emission tomography (pet) images and provides registration and fusion of these images. Pet and mr images can be acquired either simultaneously or sequentially. Anatomical...". FDA records list 7 510(k) clearances for Siemens Healthineers AG, from to . As of , FDA records show no recalls naming K253023.

Clearance record

Decision date
Received
(118 days to decision)
Product code
OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Regulation
21 CFR 892.1200
Device class
Class II
Review panel
Radiology
Applicant
Siemens Healthineers AG Siemensstr. 3, Forchheim, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OUO

Trailing 12 months
2 clearances under product code OUO in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OUO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260