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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 July 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
July 17, 2026
Date Received
December 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 (January 15, 2026)
  • K234154 — uPMR 790 (May 24, 2024)
  • K222540 — uPMR 790 (November 14, 2022)
  • K213709 — SIGNA PET/MR (January 20, 2022)
  • K200213 — Biograph mMR with syngo MR E11P-AP01 system software (May 11, 2020)
  • K192672 — uPMR 790 (November 20, 2019)
  • K183014 — uPMR 790 (February 27, 2019)
  • K172531 — Biograph mMR with mMR Angio Transfer Option (November 14, 2017)
  • K163234 — Biograph mMR with syngo MR E11P system software (February 28, 2017)
  • K163619 — SIGNA PET/MR (February 14, 2017)

FDA data resources