MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE— 510(k) K971452
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K971452 for MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE, Substantially Equivalent on 1997-05-14. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code IZZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.1980
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Iselin, NJ, US
Recent devices under product code IZZ
view allMore clearances from Siemens Medical Solutions USA, Inc.
view allRecalls naming K971452
K-number listed on FDA's recall record- Z-2180-2024 — AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395399
- Z-2181-2024 — AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395415
- Z-2182-2024 — AXIOM MULTIX MP - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395381
- Z-2183-2024 — AXIOM MULTIX MP - Inended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395431
- Z-2186-2024 — MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number:475517
- Z-2187-2024 — MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 475525
- Z-0298-2019 — AXIOM Multix MT (model number 8395415 or 8395399 or 8395381), a patient table used in conjunction with the Siemens Multix PRO- and TOP Systems radiographic exposures of the entire body.
- Z-1460-2014 — AXIOM Vertix MD Trauma systems radiographic X-ray
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K971452.
Data sourced from openFDA. This site is unofficial and independent of the FDA.