IP500 NUCLEAR GAMMA CAMERA SYSTEM— 510(k) K952109
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K952109 for IP500 NUCLEAR GAMMA CAMERA SYSTEM, Substantially Equivalent on 1995-08-23. 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
- Hoffman Estates, IL, US
Recent devices under product code KPS
view allMore clearances from Siemens Medical Solutions USA, Inc.
view allRecalls naming K952109
K-number listed on FDA's recall record- Z-0914-2015 — e.cam -emission computed tomography system Used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.
- Z-0116-2015 — e.cam line of gamma camera systems Used to detect or image the distribution of radionuclides in the body or organ.
- Z-1297-2015 — E.CAM emission computed tomography system used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K952109.
Data sourced from openFDA. This site is unofficial and independent of the FDA.