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
K163619Substantially Equivalent

Signa Pet/mr

GE Healthcare, Waukesha WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163619 is the FDA 510(k) clearance record for SIGNA PET/MR, a class II device, cleared for Ge Medical Systems, LLC 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 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show 7 recalls naming K163619.

Clearance record

Decision date
Received
(54 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
Ge Medical Systems, LLC 3200 N Grandview Blvd., Waukesha WI
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