Access CT
by Philips Healthcare (Suzhou) Co., Ltd.
Ref 728114, 728116
Access CT (728114) is a Class IIb device made by Philips Healthcare (Suzhou) Co., Ltd., registered in EUDAMED on 11 Jul 2025 (Basic UDI-DI 0884838BM284T4) and cleared under FDA 510(k) K191136 on 29 Jul 2019, active as of 25 Oct 2026.
Active
CE MDR 510(k)
Valid until
No date given
FDA recalls
None found
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0884838BM284T4 | Date11 Jul 2025 | StatusActive |
| United States | FDA 510(k) 510(k) | NumberK191136 | Date29 Jul 2019 | StatusActive |
Official records
- EUDAMED public site 0884838BM284T4
- FDA 510(k) database K191136
Across registries
- EUDAMED Basic UDI-DI 0884838BM284T4 registered 11 Jul 2025 Active
- FDA 510(k) K191136 decided 29 Jul 2019 Active
Timeline
- Cleared FDA 510(k) K191136
- Registered EUDAMED 0884838BM284T4
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- United States
- European Union
Specification
- Device name
- CT Scanner System (Access CT)
- Model / reference
- 728114, 728116
- Primary DI / UDI-DI
- 00884838059856, 00884838059849
- Basic UDI-DI
- 0884838BM284T4
- Direct marketing DI
- 0088483805985600884838059849
- EMDN code
- Z11030602, Z11030603
- Device class
- Class IIb
- System or procedure pack
- System which is a device in itself
- EU registration type
- Standard device
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000003923
- Authorised representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
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