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510(k) K200213

Biograph mMR with syngo MR E11P-AP01 system software by Siemens Medical Solutions USA, Inc. — Product Code OUO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2020
Date Received
January 28, 2020
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 by Siemens Medical Solutions USA, Inc.

  • K253574 — SOMATOM X.cite; SOMATOM X.ceed (March 20, 2026)
  • K254016 — MI View&GO (February 10, 2026)
  • K253487 — ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultras (November 17, 2025)
  • K253457 — ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ul (November 13, 2025)
  • K250241 — Cios Select (November 4, 2025)
  • K251805 — syngo.CT Dual Energy (October 15, 2025)
  • K251481 — ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ul (August 20, 2025)
  • K251561 — Biograph Trinion (July 31, 2025)
  • K251523 — Cios Spin (July 29, 2025)
  • K251061 — NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime (July 28, 2025)

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)
  • 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)
  • K142098 — SIGNA PET/MR (November 24, 2014)