WIRELESS PORTABLE DETECTOR FD-W17— 510(k) K090625
Substantially EquivalentPhilips Medical Systems North America Co.
FDA 510(k) clearance K090625 for WIRELESS PORTABLE DETECTOR FD-W17, Substantially Equivalent on 2009-03-24. Applicant: Philips Medical Systems North America Co.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems North America Co.
- 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
- Bothell, WA, US
Recent devices under product code MQB
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- K063781 — PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE
- K062268 — MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A03
Recalls naming K090625
K-number listed on FDA's recall record- Z-2841-2018 — DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082
- Z-2842-2018 — DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028
- Z-2843-2018 — DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031
- Z-2844-2018 — DigitalDiagnost Release 3 (Stitching Patient Support) 712025
- Z-2845-2018 — DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026
- Z-2846-2018 — BuckyDiagnost Ceiling System (Stitching Patient Support) 704031
- Z-2847-2018 — CombiDiagnost R90 (Stitching Patient Support) 709030
- Z-2848-2018 — DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712081
- Z-2849-2018 — DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029
- Z-2850-2018 — DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028
- Z-2851-2018 — DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027
- Z-2852-2018 — DigitalDiagnost 4.1 (Stitching Patient Support) 712225
- Z-2853-2018 — DigitalDiagnost 4.1 Chest / Emergency (Stitching Patient Support) 712029
- Z-2854-2018 — DigitalDiagnost 4.1 Flex / Value (Stitching Patient Support) 712028
- Z-2855-2018 — DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031
- Z-2856-2018 — DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081
- Z-2857-2018 — DigitalDiagnost Classic, Dual-Detector (Stitching Patient Support) 712052
- Z-2858-2018 — DigitalDiagnost Dual Detector (Stitching Patient Support) 712022
- Z-2859-2018 — DigitalDiagnost Dual Detector (Stitching Patient Support) 712022
- Z-2860-2018 — DigitalDiagnost Rel.4 Upgrades (Stitching Patient Support) 712084
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090625.
Data sourced from openFDA. This site is unofficial and independent of the FDA.