PHILIPS INTEGRIS H/HM SYSTEM— 510(k) K925302
Substantially EquivalentPhilips Medical Systems, Inc.
FDA 510(k) clearance K925302 for PHILIPS INTEGRIS H/HM SYSTEM, Substantially Equivalent on 1992-12-17. Applicant: Philips Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems, Inc.
- Product code
- Code IZF
- Device class
- Class 2
- Regulation
- 21 CFR 892.1740
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- 5680 Da Best, NL
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Recalls naming K925302
K-number listed on FDA's recall record- Z-3237-2018 — Poly C- DMCP-Visub(H3000), System Code 72238 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
- Z-3238-2018 — Cesar-DMCP-Visub(HM2000/3000), System Code 72239 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
- Z-3239-2018 — Cesar Powerpack-Visub(V3000), System Code 72243 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K925302.
Data sourced from openFDA. This site is unofficial and independent of the FDA.