Atlas FDA

PHILIPS BUCKY VISION

FDA 510(k) clearance K982795 · decided 1998-11-24

Clearance details

K-number
K982795
Device name
PHILIPS BUCKY VISION
Applicant
Philips Medical Systems, Inc.
Decision
Substantially Equivalent
Date received
1998-08-10
Decision date
1998-11-24
Days to decision
106 days
Clearance type
Traditional
Product code
MQB
Device class
2
Regulation number
892.1680
Medical specialty
Radiology
Advisory committee
Radiology
Location
Shelton, CT, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/6 recall (Z-1503-2014)Philips Medical Systems, Inc.2014-04-24
Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-Ray exposures fo recall (Z-2059-2013)Philips Healthcare Inc.2013-08-26
Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 71 recall (Z-1447-2013)Philips Healthcare Inc.2013-06-17
Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 71 recall (Z-1448-2013)Philips Healthcare Inc.2013-06-17
Philips Digital Diagnost Stationary radiographic system recall (Z-0900-2013)Philips Healthcare Inc.2013-03-01
Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 71202 recall (Z-0884-2013)Philips Healthcare Inc.2013-02-26
Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for ma recall (Z-0475-2013)Philips Healthcare Inc.2012-12-05
Philips Digital Diagnost with patient carriage Model: 712050 with serial number range from recall (Z-2494-2012)Philips Healthcare Inc.2012-09-28
Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dua recall (Z-2465-2012)Philips Healthcare Inc.2012-09-27
Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic syste recall (Z-2384-2012)Philips Healthcare Inc.2012-09-14
Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror ic recall (Z-1818-2012)Philips Healthcare Inc.2012-06-15
Philips Digital Diagnost Systems with Eleva software version 2.x and stitching option Inte recall (Z-1464-2012)Philips Healthcare Inc.2012-04-26
Philips Digital Diagnost Rel 3, a radiographic system, digital Intended use: Radiographic recall (Z-0313-2012)Philips Healthcare Inc.2011-11-30
The BABIX holder is an accessory used with the DigitalDiagnost X-ray system. It is used to recall (Z-0022-2011)Philips Medical Systems North America Co. Phillips2010-10-07
DigitalDiagnost X-ray System is a stationary Diagnostic X-ray using Digital Solid State Im recall (Z-2422-2010)Philips Medical Systems North America Co. Phillips2010-09-14
DigitalDiagnost. General radiographic examinations and applications wherever a solid state recall (Z-0847-2010)Philips Medical Systems North America Co. Phillips2010-03-23
Philips Digital Diagnost X-Ray system recall (Z-0908-2007)Philips Medical Systems North America Co. Phillips2007-09-25

PMA approvals by this applicant

RecordFirmDate
HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) (P160029/S028)Philips Medical Systems, Inc.2025-06-20
HeartStart Home Defibrillator (M5068A) and HeartStart Onsite Defibrillator (M5066A) (P160029/S027)Philips Medical Systems, Inc.2025-06-09
HeartStart FR3 Defibrillator (P160028/S006)Philips Medical Systems, Inc.2025-05-09
HeartStart Home Defibrillator, HeartStart OnSite Defibrillator, HeartStart HS1 SMART Pads, Adult (M5071A), HeartStart HS (P160029/S026)Philips Medical Systems, Inc.2024-12-12
HeartStart FR3 Primary Battery (989803150161) (P160028/S005)Philips Medical Systems, Inc.2024-09-11
HeartStart HS1 Onsite Defibrillator (M5066A), HeartStart HS1 Home Defibrillator (M5068A) (P160029/S024)Philips Medical Systems, Inc.2024-02-21
HeartStart OnSite Defibrillator, HeartStart Home Defibrillator, HeartStart HS1 SMART Pads, Adult, HeartStart HS1 SMART P (P160029/S022)Philips Medical Systems, Inc.2024-01-23
HeartStart OnSite Defibrillator and HeartStart Home Defibrillator (P160029/S023)Philips Medical Systems, Inc.2024-01-05