Atlas FDA

WIRELESS PORTABLE DETECTOR FD-W17

FDA 510(k) clearance K090625 · decided 2009-03-24

Clearance details

K-number
K090625
Device name
WIRELESS PORTABLE DETECTOR FD-W17
Applicant
Philips Medical Systems North America Co.
Decision
Substantially Equivalent
Date received
2009-03-09
Decision date
2009-03-24
Days to decision
15 days
Clearance type
Traditional
Product code
MQB
Device class
2
Regulation number
892.1680
Medical specialty
Radiology
Advisory committee
Radiology
Location
Bothell, WA, US
Third-party review
Yes
Expedited review
No

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Recalls involving this device

RecordFirmDate
DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082 recall (Z-2841-2018)Philips Medical Systems Gmbh, DMC2018-08-17
DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028 recall (Z-2842-2018)Philips Medical Systems Gmbh, DMC2018-08-17
DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031 recall (Z-2843-2018)Philips Medical Systems Gmbh, DMC2018-08-17
DigitalDiagnost Release 3 (Stitching Patient Support) 712025 recall (Z-2844-2018)Philips Medical Systems Gmbh, DMC2018-08-17
DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026 recall (Z-2845-2018)Philips Medical Systems Gmbh, DMC2018-08-17
BuckyDiagnost Ceiling System (Stitching Patient Support) 704031 recall (Z-2846-2018)Philips Medical Systems Gmbh, DMC2018-08-17
CombiDiagnost R90 (Stitching Patient Support) 709030 recall (Z-2847-2018)Philips Medical Systems Gmbh, DMC2018-08-17
DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712081 recall (Z-2848-2018)Philips Medical Systems Gmbh, DMC2018-08-17
DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029 recall (Z-2849-2018)Philips Medical Systems Gmbh, DMC2018-08-17
DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028 recall (Z-2850-2018)Philips Medical Systems Gmbh, DMC2018-08-17
DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027 recall (Z-2851-2018)Philips Medical Systems Gmbh, DMC2018-08-17
DigitalDiagnost 4.1 (Stitching Patient Support) 712225 recall (Z-2852-2018)Philips Medical Systems Gmbh, DMC2018-08-17
DigitalDiagnost 4.1 Chest / Emergency (Stitching Patient Support) 712029 recall (Z-2853-2018)Philips Medical Systems Gmbh, DMC2018-08-17
DigitalDiagnost 4.1 Flex / Value (Stitching Patient Support) 712028 recall (Z-2854-2018)Philips Medical Systems Gmbh, DMC2018-08-17
DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031 recall (Z-2855-2018)Philips Medical Systems Gmbh, DMC2018-08-17
DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081 recall (Z-2856-2018)Philips Medical Systems Gmbh, DMC2018-08-17
DigitalDiagnost Classic, Dual-Detector (Stitching Patient Support) 712052 recall (Z-2857-2018)Philips Medical Systems Gmbh, DMC2018-08-17
DigitalDiagnost Dual Detector (Stitching Patient Support) 712022 recall (Z-2858-2018)Philips Medical Systems Gmbh, DMC2018-08-17
DigitalDiagnost Dual Detector (Stitching Patient Support) 712022 recall (Z-2859-2018)Philips Medical Systems Gmbh, DMC2018-08-17
DigitalDiagnost Rel.4 Upgrades (Stitching Patient Support) 712084 recall (Z-2860-2018)Philips Medical Systems Gmbh, DMC2018-08-17
DigitalDiagnost Release 3 (Stitching Patient Support) 712025 recall (Z-2861-2018)Philips Medical Systems Gmbh, DMC2018-08-17
DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026 recall (Z-2862-2018)Philips Medical Systems Gmbh, DMC2018-08-17
DigitalDiagnost Single Detector (Stitching Patient Support) 712020 recall (Z-2863-2018)Philips Medical Systems Gmbh, DMC2018-08-17
DigitalDiagnost Upgrades (Stitching Patient Support) 712083 recall (Z-2864-2018)Philips Medical Systems Gmbh, DMC2018-08-17
DigitalDiagnost, Dual-Detector (Stitching Patient Support) 712052 recall (Z-2865-2018)Philips Medical Systems Gmbh, DMC2018-08-17
DigitalDiagnost, Single-Detect (Stitching Patient Support) 712062 recall (Z-2866-2018)Philips Medical Systems Gmbh, DMC2018-08-17
EasyDiagnost Eleva DRF (Stitching Patient Support) 706032 recall (Z-2867-2018)Philips Medical Systems Gmbh, DMC2018-08-17
EasyDiagnost Eleva DRF, Release 5 (Stitching Patient Support) 706050 recall (Z-2868-2018)Philips Medical Systems Gmbh, DMC2018-08-17