PHILIPS BUCKY VISION— 510(k) K982795
Substantially EquivalentPhilips Medical Systems, Inc.
FDA 510(k) clearance K982795 for PHILIPS BUCKY VISION, Substantially Equivalent on 1998-11-24. Applicant: Philips Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems, Inc.
- Product code
- Code MQB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shelton, CT, US
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Recalls naming K982795
K-number listed on FDA's recall record- Z-1503-2014 — Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85
- Z-2059-2013 — Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-Ray exposures for diagnostics.
- Z-1447-2013 — Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD Applications
- Z-1448-2013 — Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD Applications
- Z-0475-2013 — Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics
- Z-0900-2013 — Philips Digital Diagnost Stationary radiographic system
- Z-0884-2013 — Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital radiographic system
- Z-2494-2012 — Philips Digital Diagnost with patient carriage Model: 712050 with serial number range from 00 000 00 to 09 000 543. Product Usage: Stationary radiographic System
- Z-2465-2012 — Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dual Detector, Release 3) System codes: 712020, 712022, 712025 This system is used for making X-ray exposures for diagnostics.
- Z-2384-2012 — Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications
- Z-1818-2012 — Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon Stationary Fluoroscopic system
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K982795.
Data sourced from openFDA. This site is unofficial and independent of the FDA.