VERTEX EPIC MCD— 510(k) K952684
Substantially EquivalentAdac Laboratories
FDA 510(k) clearance K952684 for VERTEX EPIC MCD, Substantially Equivalent on 1995-11-24. Applicant: Adac Laboratories. Device class: 2.
Clearance details
- Applicant
- Adac Laboratories
- 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
- Milpitas, CA, US
Recent devices under product code KPS
view allMore clearances from Adac Laboratories
view allRecalls naming K952684
K-number listed on FDA's recall record- Z-1598-2015 — Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH
- Z-1510-2014 — Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Cleveland, OH 44143. Used to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K952684.
Data sourced from openFDA. This site is unofficial and independent of the FDA.