Biograph mCT Family of PET/CT Systems— 510(k) K173578
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K173578 for Biograph mCT Family of PET/CT Systems, Substantially Equivalent on 2017-12-20. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Knoxville, TN, US
Recent devices under product code KPS
view allMore clearances from Siemens Medical Solutions USA, Inc.
view allRecalls naming K173578
K-number listed on FDA's recall record- Z-0178-2019 — Biograph mCT: a) S(64)-3R, Material Number 10248669 b) S (20) -3R, Material Number 10507786 c) Flow 20-4R, Material Number 10528958 d) m Flow 64-4R, Material Number 10529161 e) mCT S(40)-4R, Material Number 10248671 f) mCT S(64)-4R, Material Number 0248672 g) mCT S(20)-3R, Material Number 10534159 h) mCT Flow Edge-4R, Material Number 10528955 i) mCT Flow 40-3R, Material Number 10529158 j) mCT Flow 64-3R, Material Number 10529160 k) mCT X-4R, Material Number 10248670 l) mCT X-3R, Material Number 10248673 m) mCT S(20)-4R, Material Number 10534160 n) mCT S(40)-3R, Material Number 10248668 o) mCT Flow 40-4R, Material Number 10529159 p) mCT Flow 20-3R, Material Number 10528956 q) mCT Flow Edge-3R, Material Number 10528954 The Siemens Biograph Horizon and Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
- Z-2248-2018 — Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. (b) Biograph mCT S(40)-4R, Material Number 10248671 (c) Biograph mCT S(64)-4R, Material Number 10248672 (d) Biograph mCT X-4R, Material Number 10248670 (e) Biograph mCT X-3R, Material Number 10248673 (f) BIOGRAPH mCT 20 Excel, Material Number 10507786 (g) Biograph mCT Flow Edge-4R, Material Number 10528955 (h) Biograph mCT S(40)-3R, Material Number 10248668 (i) Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 (j) Biograph mCT Flow 40-4R, Material Number 10529159 (k) Biograph mCT-X w/TrueV Upgrade, Material Number 10250745
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173578.
Data sourced from openFDA. This site is unofficial and independent of the FDA.