Discovery MI— 510(k) K161574
Substantially EquivalentGe Medical Systems, LLC
FDA 510(k) clearance K161574 for Discovery MI, Substantially Equivalent on 2016-08-11. 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 K161574
K-number listed on FDA's recall record- Z-1749-2019 — Discovery Ml 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-2580-2018 — Discovery MI, labeled as Discovery DMI 15 cm 3 ring, and Discovery DMI 20cm 4 ring
- Z-2193-2017 — GE Healthcare Discovery Ml X-ray system
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161574.
Data sourced from openFDA. This site is unofficial and independent of the FDA.