MR 5300 and MR 7700 R11 MR Systems
FDA 510(k) clearance K223442 · decided 2022-12-23
Clearance details
- K-number
- K223442
- Device name
- MR 5300 and MR 7700 R11 MR Systems
- Applicant
- Philips Medical Systems Nederlands B.V.
- Decision
- Substantially Equivalent
- Date received
- 2022-11-14
- Decision date
- 2022-12-23
- Days to decision
- 39 days
- Clearance type
- Special
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Best, NL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1 recall (Z-1214-2026) | Philips North America | 2026-01-29 |
| MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152; recall (Z-2213-2025) | Philips North America | 2025-07-30 |
| Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152; recall (Z-1804-2025) | Philips North America Llc | 2025-05-16 |