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FDA-cleared K252992

CT Rembra RT; CT Areta RT; CT Rembra

Philips Healthcare (Suzhou) Co., Ltd.

Authorized purpose: CT Rembra RT, CT Areta RT, and CT Rembra support whole-body diagnostic imaging, oncology, radiotherapy planning, interventional, vascular, neurological, cardiovascular, and qualified lung-screening workflows for all ages.

Modality
CT/CTA
Anatomy
Multi-region
Decision
2026-03-23
FDA-cleared K232491

CT 5300

Philips Healthcare (Suzhou) Co., Ltd.

CT 5300 acquires head and whole-body cross-sectional CT images for diagnosis in adult and pediatric patients and supports low-dose lung-cancer screening under approved protocols.

Modality
CT/CTA
Anatomy
Multi-region
Decision
2024-05-03
FDA-cleared K223311

Philips CT 3500

Philips Healthcare (Suzhou) Co., Ltd

Authorized purpose: The Philips CT 3500 produces CT images of the head and body and is indicated for head, whole-body, cardiac-calcium-scoring, and vascular CT in patients of all ages; it is also labeled for low-dose CT lung-cancer screening within established governmental or professional-society program criteria.

Modality
CT/CTA
Anatomy
Head, whole body, cardiac, vascular, and lung-screening anatomy
Decision
2022-12-22
FDA-cleared K212441

Philips Incisive CT

Philips Healthcare (Suzhou) Co., Ltd.

Philips Incisive CT provides head, whole-body, cardiac, and vascular CT imaging for patients of all ages and can support qualified low-dose lung screening under labeled programs and protocols.

Modality
CT/CTA
Anatomy
Multi-region
Decision
2022-04-27
FDA-cleared K203514

Precise Position

Philips Healthcare (Suzhou) Co., Ltd.

Precise Position uses a ceiling-mounted color and depth camera with a convolutional neural network to assist positioning patients aged 16 years and older on Philips Incisive CT by identifying orientation, recommending surview range, and centering head, chest, abdominal, or pelvic anatomy.

Modality
CT/CTA
Anatomy
Multi-region
Decision
2021-06-17