DISCOVERY PET/CT 710— 510(k) K133657
Substantially EquivalentGe Medical Systems, LLC
FDA 510(k) clearance K133657 for DISCOVERY PET/CT 710, Substantially Equivalent on 2014-03-21. Applicant: Ge Medical Systems, LLC. Device class: 2.
Clearance details
- Applicant
- Ge Medical Systems, LLC
- 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
- Waukesha, WI, US
Recent devices under product code KPS
view allMore clearances from Ge Medical Systems, LLC
view allRecalls naming K133657
K-number listed on FDA's recall record- Z-1746-2019 — Discovery PET/CT 710 Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
- Z-1750-2019 — Discovery Ml DR Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
- Z-2579-2018 — Discovery MI Digital Ready
- Z-2191-2017 — GE Healthcare Discovery Ml DR X-ray system
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133657.
Data sourced from openFDA. This site is unofficial and independent of the FDA.