PHILIPS BUCKY DIAGNOST FAMILY— 510(k) K945278
Substantially EquivalentPhilips Medical Systems North America, Inc.
FDA 510(k) clearance K945278 for PHILIPS BUCKY DIAGNOST FAMILY, Substantially Equivalent on 1994-12-14. Applicant: Philips Medical Systems North America, Inc.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems North America, Inc.
- Product code
- Code KPR
- 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
Recent devices under product code KPR
view allMore clearances from Philips Medical Systems North America, Inc.
view all- K102005 — ALLURA XPER OR TABLE SERIES
- K062233 — HEARTSTART MRX MONITOR/DEFIBRILLATOR
- K062283 — THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORS
- K061052 — THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90
- K050151 — MULTIDIAGNOST ELEVA
Adverse events under product code KPR
product code KPR- Other
- 6
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K945278
K-number listed on FDA's recall record- Z-1806-2020 — Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.
- Z-0766-2016 — Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diagnosis.
- Z-0364-2016 — Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037
- Z-1449-2013 — Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making x-ray exposures for diagnostics.
- Z-1450-2013 — Philips BuckyDiagnost Radiographic. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making x-ray exposures for diagnostics
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K945278.
Data sourced from openFDA. This site is unofficial and independent of the FDA.