FDA-cleared K260667

Alturion Series Diagnostic Ultrasound System

Philips Ultrasound, LLC

Alturion Series diagnostic ultrasound systems acquire and display ultrasound images and fluid-flow information for the labeled fetal, abdominal, cardiac, cephalic, obstetric,...

Modality
Ultrasound
Anatomy
Fetus; abdomen; pelvis; small organs; head; heart; peripheral vessels; musculoskeletal anatomy; ophthalmic; urologic organs; and lung
Decision
2026-06-29
FDA-cleared K260123

EPIQ Series Diagnostic Ultrasound System

Philips Ultrasound, LLC

EPIQ diagnostic ultrasound systems acquire and display ultrasound images and fluid-flow information for the labeled fetal, abdominal, cardiac, cephalic, obstetric,...

Modality
Ultrasound
Anatomy
Fetus; abdomen; pelvis; small organs; head; heart; peripheral vessels; musculoskeletal anatomy; and urologic organs
Decision
2026-05-27
FDA-cleared K260680

EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems

Philips Ultrasound, LLC

EPIQ and Affiniti ultrasound systems acquire and display the labeled diagnostic ultrasound and fluid-flow information across fetal, abdominal, cardiac, cephalic, obstetric,...

Modality
Ultrasound
Anatomy
Fetus; abdomen; pelvis; small organs; head; heart; peripheral vessels; musculoskeletal anatomy; and urologic organs
Decision
2026-05-27
FDA-cleared K252558

Lumify Diagnostic Ultrasound System

Philips Ultrasound, LLC

Diagnostic ultrasound; assisted abdominal FAST acquisition and anatomical labeling

Modality
Ultrasound
Anatomy
Abdomen; Heart/Cardiovascular; Obstetric/Gynecologic; Musculoskeletal; Lung; Small parts
Decision
2026-05-05
FDA-cleared K252557

Lumify Diagnostic Ultrasound System

Philips Ultrasound, LLC

Lumify Lung Application 3 assesses pleural-line appearance and lung-view quality in adults at least 18 years old using compatible Android devices and specified probes; it does not...

Modality
Ultrasound
Anatomy
Lung
Decision
2025-12-22
FDA-cleared K251651

EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

Philips Ultrasound, LLC

EPIQ and Affiniti are diagnostic ultrasound systems for imaging and fluid-flow assessment across the labeled adult, pediatric, fetal, cardiac, vascular, abdominal, small-organ,...

Modality
Ultrasound
Anatomy
Abdominal, cardiac, cerebral vascular, fetal, gynecologic, musculoskeletal, lung, small-organ, thoracic, and urologic anatomy
Decision
2025-10-09
FDA-cleared K251455

EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

Philips Ultrasound LLC

EPIQ and Affiniti diagnostic ultrasound systems acquire and display the labeled fetal, abdominal, cardiac, cephalic, obstetric, musculoskeletal, vascular, small-organ, and...

Modality
Ultrasound
Anatomy
Fetus; abdomen; pelvis; small organs; head; heart; peripheral vessels; musculoskeletal anatomy; and urologic organs
Decision
2025-07-24
FDA-cleared K250886

EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems

Philips Ultrasound LLC

EPIQ and Affiniti are diagnostic ultrasound systems for imaging and fluid-flow analysis of the human body across the labeled abdominal, cardiac, vascular, fetal, gynecologic,...

Modality
Ultrasound
Anatomy
Abdomen, heart, cerebral and peripheral vessels, cephalic, fetal, gynecologic, musculoskeletal, ophthalmic, urologic, breast, thyroid, testicle, lung, and procedural anatomy
Decision
2025-06-18
FDA-cleared K243793

EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

Philips Ultrasound LLC

EPIQ and Affiniti are diagnostic ultrasound systems for imaging and fluid-flow analysis of the human body across the labeled abdominal, cardiac, vascular, fetal, gynecologic,...

Modality
Ultrasound
Anatomy
Abdomen, heart, cerebral and peripheral vessels, cephalic, fetal, gynecologic, musculoskeletal, ophthalmic, urologic, breast, thyroid, testicle, lung, and procedural anatomy
Decision
2025-05-21
FDA-cleared K251110

EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems

Philips Ultrasound LLC

EPIQ and Affiniti are diagnostic ultrasound systems for imaging and fluid-flow analysis of the human body across the labeled abdominal, cardiac, vascular, fetal, gynecologic,...

Modality
Ultrasound
Anatomy
Abdomen, heart, cerebral and peripheral vessels, cephalic, fetal, gynecologic, musculoskeletal, ophthalmic, urologic, breast, thyroid, testicle, lung, and procedural anatomy
Decision
2025-05-09
FDA-cleared K250177

EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

Philips Ultrasound LLC

EPIQ and Affiniti are diagnostic ultrasound systems for imaging and fluid-flow analysis of the human body across the labeled abdominal, cardiac, vascular, fetal, gynecologic,...

Modality
Ultrasound
Anatomy
Abdomen, heart, cerebral and peripheral vessels, cephalic, fetal, gynecologic, musculoskeletal, ophthalmic, urologic, breast, thyroid, testicle, lung, and procedural anatomy
Decision
2025-04-10
FDA-cleared K241659

Ultrasound Workspace (UWS 6.0)

Philips Ultrasound LLC

Ultrasound Workspace reviews, quantifies, and reports structures and function from multidimensional digital medical data from different modalities in cardiovascular, fetal, and...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Cardiovascular, fetal, and abdominal anatomy represented in multidimensional medical data
Decision
2025-02-10
FDA-cleared K243794

EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

Philips Ultrasound LLC

EPIQ and Affiniti are diagnostic ultrasound systems for imaging and fluid-flow analysis of the human body across the labeled abdominal, cardiac, vascular, fetal, gynecologic,...

Modality
Ultrasound
Anatomy
Abdomen, heart, cerebral and peripheral vessels, cephalic, fetal, gynecologic, musculoskeletal, ophthalmic, urologic, breast, thyroid, testicle, lung, and procedural anatomy
Decision
2025-02-06
FDA-cleared K242020

EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

Philips Ultrasound LLC

The EPIQ and Affiniti systems are intended for diagnostic ultrasound imaging and fluid-flow analysis of the human body. The FDA indication lists abdominal, adult, fetal and...

Modality
Ultrasound
Anatomy
Fetal/obstetric, abdominal, pelvic, cardiac, vascular, cephalic, small-organ, musculoskeletal, ophthalmic, pulmonary, and urologic anatomy
Decision
2024-12-12
FDA-cleared K242800

The 5000 Compact Series Ultrasound Systems

Philips Ultrasound LLC

The 5000 Compact ultrasound systems are intended for diagnostic ultrasound imaging and fluid-flow analysis of the human body. The FDA indication lists abdominal, adult and...

Modality
Ultrasound
Anatomy
Fetal/obstetric, abdominal, pelvic, cardiac, vascular, cephalic, small-organ, musculoskeletal, ophthalmic, pulmonary, and urologic anatomy
Decision
2024-11-15
FDA-cleared K240980

EPIQ Series Diagnostic Ultrasound System

Philips Ultrasound LLC

The EPIQ ultrasound diagnostic system is intended for diagnostic ultrasound imaging and fluid-flow analysis of the human body. The FDA material lists abdominal, adult, fetal and...

Modality
Ultrasound
Anatomy
Fetal/obstetric, abdominal, pelvic, cardiac, vascular, cephalic, small-organ, musculoskeletal, ophthalmic, pulmonary, and urologic anatomy
Decision
2024-10-07
FDA-cleared K240850

EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems

Philips Ultrasound LLC

The EPIQ and Affiniti systems are intended for diagnostic ultrasound imaging and fluid-flow analysis of the human body. The FDA material lists adult, fetal and pediatric cardiac,...

Modality
Ultrasound
Anatomy
Fetal/obstetric, abdominal, pelvic, cardiac, vascular, cephalic, small-organ, musculoskeletal, pulmonary, and urologic anatomy
Decision
2024-04-24
FDA-cleared K233545

EPIQ Series Diagnostic Ultrasound System

Philips Ultrasound LLC

EPIQ Series Diagnostic Ultrasound System provides diagnostic ultrasound imaging and fluid-flow analysis across the labeled clinical applications; exact probes, modes, anatomies,...

Modality
Ultrasound
Anatomy
Multi-region
Decision
2023-11-30
FDA-cleared K231190

EPIQ Series Diagnostic Ultrasound System

Philips Ultrasound LLC

The K231190 EPIQ submission adds the mL26-8 linear-array transducer for labeled high-resolution superficial, musculoskeletal, ophthalmic, pediatric, peripheral-vessel, breast,...

Modality
Ultrasound
Anatomy
Multi-region
Decision
2023-05-12