Access CT
System, X-ray, Tomography, Computed
Philips Healthcare (Suzhou) Co., Ltd.
The following data is part of a premarket notification filed by Philips Healthcare (suzhou) Co., Ltd. with the FDA for Access Ct.
Pre-market Notification Details
| Device ID | K191136 |
| 510k Number | K191136 |
| Device Name: | Access CT |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Philips Healthcare (Suzhou) Co., Ltd. No.258, ZhongYuan Road, Suzhou Industrial Park Suzhou, CN 215024 |
| Contact | Ray Sun |
| Correspondent | Ray Sun Philips Healthcare (Suzhou) Co., Ltd. No.258, ZhongYuan Road, Suzhou Industrial Park Suzhou, CN 215024 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-29 |
| Decision Date | 2019-07-29 |
| Summary: | summary |
Trademark Results [Access CT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACCESS CT 79177675 not registered Dead/Abandoned |
Koninklijke Philips N.V. 2015-10-15 |
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