Precise Position
by Philips Healthcare (Suzhou) Co., Ltd.
510(k) K203514
Precise Position is a Class II device made by Philips Healthcare (Suzhou) Co., Ltd., cleared under FDA 510(k) K203514 on 17 Jun 2021, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK203514 | Date17 Jun 2021 | StatusActive |
Official records
- FDA 510(k) database K203514
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JAK
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1750
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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