AUTOSPECT— 510(k) K090403
Substantially EquivalentPhilips Medical Systems (Cleveland), Inc.
FDA 510(k) clearance K090403 for AUTOSPECT, Substantially Equivalent on 2009-03-31. Applicant: Philips Medical Systems (Cleveland), Inc.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems (Cleveland), 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
- Cleveland, OH, US
Recent devices under product code KPS
view allMore clearances from Philips Medical Systems (Cleveland), Inc.
view allRecalls naming K090403
K-number listed on FDA's recall record- Z-1504-2016 — Extended Brilliance Workspace NM Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical Systems, Cleveland, OH. Provides software applications used to process, analyze, and display medical images/data.
- Z-1505-2016 — Extended Brilliance Workspace NM Special Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical Systems, Cleveland, OH. Provides software applications used to process, analyze, and display medical images/data.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090403.
Data sourced from openFDA. This site is unofficial and independent of the FDA.