MR 5300 and MR 7700 R11 MR Systems— 510(k) K223442
Substantially EquivalentPhilips Medical Systems Nederlands B.V.
FDA 510(k) clearance K223442 for MR 5300 and MR 7700 R11 MR Systems, Substantially Equivalent on 2022-12-23. Applicant: Philips Medical Systems Nederlands B.V.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems Nederlands B.V.
- Product code
- Code LNH
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Best, NL
Recent devices under product code LNH
view allMore clearances from Philips Medical Systems Nederlands B.V.
view allAdverse events under product code LNH
product code LNH- Death
- 11
- Injury
- 670
- Malfunction
- 1,460
- Other
- 2
- Total
- 2,143
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 K223442
K-number listed on FDA's recall record- Z-1214-2026 — Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.
- Z-2213-2025 — MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;
- Z-1804-2025 — Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K223442.
Data sourced from openFDA. This site is unofficial and independent of the FDA.