Biograph Vision, Biograph mCT Family of PET/CTs— 510(k) K193248
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K193248 for Biograph Vision, Biograph mCT Family of PET/CTs, Substantially Equivalent on 2020-02-14. 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
- Traditional
- Location
- Knoxville, TN, US
Recent devices under product code KPS
view allMore clearances from Siemens Medical Solutions USA, Inc.
view allRecalls naming K193248
K-number listed on FDA's recall record- Z-1135-2023 — SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R Seismic, f) S(20)-3R Mobile
- Z-1136-2023 — SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K193248.
Data sourced from openFDA. This site is unofficial and independent of the FDA.