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510(k) K253963

Cubresa BrainPET by Cubresa, Inc. — Product Code OUO

K253963 is an FDA 510(k) premarket notification submitted by Cubresa, Inc. for the device "Cubresa BrainPET". The FDA issued a decision of Substantially Equivalent on Jul 17, 2026. The device falls under product code OUO (Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance), a Class II device regulated under 21 CFR 892.1200.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 17, 2026
Date Received
Dec 11, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Device Class
Class II
Regulation Number
892.1200
Review Panel
RA
Submission Type

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 mr images are used for pet attenuation correction.

Other clearances for product code OUO

  • K253023 — BIOGRAPH One (Jan 15, 2026)
  • K234154 — uPMR 790 (May 24, 2024)
  • K222540 — uPMR 790 (Nov 14, 2022)
  • K213709 — SIGNA PET/MR (Jan 20, 2022)
  • K200213 — Biograph mMR with syngo MR E11P-AP01 system software (May 11, 2020)
  • K192672 — uPMR 790 (Nov 20, 2019)
  • K183014 — uPMR 790 (Feb 27, 2019)
  • K172531 — Biograph mMR with mMR Angio Transfer Option (Nov 14, 2017)
  • K163234 — Biograph mMR with syngo MR E11P system software (Feb 28, 2017)
  • K163619 — SIGNA PET/MR (Feb 14, 2017)

FDA data resources