DuraDiagnost
by Philips Healthcare (Suzhou) Co., Ltd.
510(k) K201640
DuraDiagnost is a Class II device made by Philips Healthcare (Suzhou) Co., Ltd., cleared under FDA 510(k) K201640 on 9 Jul 2020, active as of 22 Oct 2026. 2 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
2 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK201640 | Date9 Jul 2020 | StatusActive |
Official records
- FDA 510(k) database K201640
Recalls
-
- Ongoing Z-1553-2025
- Ongoing Z-1554-2025
Potential for collimator to fall as a result of incorrect installation.
Timeline
- Cleared FDA 510(k) K201640
- Recall initiated FDA recalls Z-1553-2025
- Recall initiated FDA recalls Z-1554-2025
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KPR
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K201640
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| DuraDiagnost | 712203 / DuraDiagnost | 00884838095205 | — | No longer on the market |
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Other devices from Philips Healthcare (Suzhou) Co., Ltd.
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