510(k) K103429
- Device
- BIOGRAPH MMR
- Applicant
- SIEMENS MEDICAL SOLUTIONS USA INC.
- 510(k) number
- K103429
- Product code
- OUO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-06-08
- Date received
- 2010-11-22
- Regulation
- 892.1200
- Classification name
- Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ALAINE MEDIO
- Address
- 810 Innovation Dr. Knoxville TN US 37932 37932
FDA Registration Numbers#
- 3004754211
- 3005326970
- 3011950073
- 3011015597
- 3015232217
- 2183553
- 3010949642
- 3015329423
- 3002808157
- 2247992
- 1529041
Source Documents#
Other 510(k) Records For Product Code OUO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253023 | BIOGRAPH One | Siemens Healthineers AG | 2026-01-15 |
| K234154 | uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | 2024-05-24 |
| K222540 | uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | 2022-11-14 |
| K213709 | SIGNA PET/MR | Ge Medical Systems, LLC | 2022-01-20 |
| K200213 | Biograph mMR with syngo MR E11P-AP01 system software | Siemens Medical Solutions USA, Inc. | 2020-05-11 |
| K192672 | uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | 2019-11-20 |
| K183014 | uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | 2019-02-27 |
| K172531 | Biograph mMR with mMR Angio Transfer Option | Siemens Medical Solutions USA, Inc. | 2017-11-14 |
| K163234 | Biograph mMR with syngo MR E11P system software | Siemens Medical Solutions USA, Inc. | 2017-02-28 |
| K163619 | SIGNA PET/MR | Ge Medical Systems, LLC | 2017-02-14 |
| K142098 | SIGNA PET/MR | Ge Medical Systems, LLC | 2014-11-24 |
| K133226 | BIOGRAPH MMR | Siemens Medical Solutions USA, Inc. | 2013-11-12 |
| K103483 | INGENUITY TF PET/MR | Philips Healthcare (Cleveland) | 2011-11-23 |
Legacy Summary#
summary
FDA Review#
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