# K940942: Combison 530 Diagnostic Ultrasound Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Medison America, Inc.
- Decided: Feb 19, 1997 after 1,086 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
737 later devices descend from it; 3 cite it directly.
0 of 738 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Kretztechnik Diagnostic Ultrasound Scanner COMBISON 330: named in the summary without a submission number
- (no number) Toshiba Diagnostic Ultrasound Scanner SSH-140A: named in the summary without a submission number
- (no number) Siemens Diagnostic Ultrasound Scanner SONOLINE SI-450: named in the summary without a submission number
- (no number) Kretztechnik Sector Transducer AWP 3.5/A: named in the summary without a submission number
- (no number) Kretztechnik Sector Transducer AW 4/5 B/A: named in the summary without a submission number
- (no number) Kretztechnik Sector Transducer NW 17.5 B/A: named in the summary without a submission number
- (no number) Kretztechnik Transrectal Transducer VRW 177 AK/A: named in the summary without a submission number
- (no number) Kretztechnik Transrectal Transducer IRW 177 AK/A: named in the summary without a submission number
- (no number) Kretztechnik Transvaginal/Urologic Transducer WIW 17.5 AP/A: named in the summary without a submission number
- (no number) Kretztechnik Transvaginal Transducer IR 15/7 BG/A: named in the summary without a submission number
- (no number) Acoustic Imaging Convex Sector Transducer CLA 3.5: named in the summary without a submission number
- (no number) Acoustic Imaging Convex Sector Transducer CLA 5.0: named in the summary without a submission number
- (no number) Acoustic Imaging Linear Array Transducer MLA 7.5: named in the summary without a submission number

## Most influential descendants
- K034003: Hdi 5000 Diagnostic Ultrasound System (2004), 677 descendants of its own
- K053069: Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series) (2005), 676 descendants of its own
- K080935: Sonix MDP Ultrasound Scanner (2008), 584 descendants of its own
- K083095: Sonixtouch Ultrasound System (2008), 582 descendants of its own
- K092271: GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 (2009), 569 descendants of its own

## Indications for use
This device is intended for use with the listed transducers for the transcutaneous, transrectal, and transvaginal imaging of organs or structures as an aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria; and in obstetric patients for the transcutaneous, or transvaginal imaging of the fetus and uterine structures including the performance of fetal measurements for the purpose of assessing fetal growth and maturity. This device is intended for use with the COMBISON® 530 system for the transcutaneous imaging of intraabdominal organs and structures including the gastrointestinal tract, kidney, bladder, etc. as an aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria; and in obstetric patients for the transcutaneous imaging of the fetus and uterine structures including the performance of fetal measurements for the purpose of assessing fetal growth and maturity. This device is intended for use with the COMBISON® 530 system for the transcutaneous imaging of intraabdominal organs and structures including the gastrointestinal tract, kidney, bladder, etc. as an aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria; and in obstetric patients for the transcutaneous imaging of the fetus and uterine structures including -the performance of fetal measurements for the purpose of assessing fetal growth and maturity. This device is intended for use with the COMBISON® 530 system for the transcutaneous imaging of intraabdominal organs and structures including the gastrointestinal tract, kidney, bladder, etc. as an aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria; and in obstetric patients for the transcutaneous imaging of the fetus and uterine structures including the performance of fetal measurements for the purpose of assessing fetal growth and maturity. This device is intended for use with the COMBISON* 530 system for the transcutaneous imaging of intraabdominal organs and structures including the gastrointestinal tract, kidney, bladder, etc. as an aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria; and in obstetric patients for the transcutaneous imaging of the fetus and uterine structures including the performance of fetal measurements for the purpose of assessing fetal growth and maturity. This device is intended for use with the COMBISON® 530 system for the transcutaneous imaging of intraabdominal organs and structures including the gastrointestinal tract, kidney, bladder, etc. as an aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria; and in obstetric patients for the transcutaneous imaging of the fetus and uterine structures including the performance of fetal measurements for the purpose of assessing fetal growth and maturity. This device is intended for use with the COMBISON* 530 system for the transcutaneous imaging of intraabdominal organs and structures including the gastrointestinal tract, kidney, bladder, etc. as an aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria; and in obstetric patients for the transcutaneous imaging of the fetus and uterine structures including the performance of fetal measurements for the purpose of assessing fetal growth and maturity. This device is intended for use with the COMBISON* 530 system for the transcutaneous imaging of peripheral vessels and small organs including breast, thyroid, testes, etc. as an aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria. This device is intended for use with the COMBISON® 530 system for the transrectal imaging of the rectum and surrounding organs and structures including the rectum wall, prostate gland, etc. as an aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria. An approved biopsy attachement is available for use with this transducer. This device is intended for use with the COMBISON* 530 system in the imaging of the fetus and uterine structures utilizing the transvaginal approach as an aid in the diagnosis of obstetrical and gynecological conditions including the performance of fetal measurements for the purpose of assessing fetal growth and maturity. An approved biopsy attachement is available for use with this transducer. This device is intended for use with the COMBISON* 530 system in the imaging of the fetus and uterine structures utilizing the transvaginal approach as an aid in the diagnosis of obstetrical and gynecological conditions including the performance of fetal measurements for the purpose of assessing fetal growth and maturity. An approved biopsy attachement is available for use with this transducer. This device is intended for use with the COMBISON* 530 system for the transcutaneous imaging of intraabdominal organs and structures including the gastrointestinal tract, kidney, bladder, etc. as an aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria; and in obstetric patients for the transcutaneous imaging of the fetus and uterine structures including the performance of fetal measurements for the purpose of assessing fetal growth and maturity. This device is intended for use with the COMBISON® 530 system for the transcutaneous imaging of intraabdominal organs and structures including the gastrointestinal tract, kidney, bladder, etc. as an aid in the detection and assessment of physical and functional abnormalities using’ established diagnostic criteria; and in obstetric patients for the transcutaneous imaging of the fetus and uterine structures including the performance of fetal measurements for the purpose of assessing fetal growth and maturity. This device is intended for use with the COMBISON* 530 system for the transcutaneous imaging of peripheral vessels and small organs including breast, thyroid, testes, etc. as an aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria.

Source page: https://510kreport.com/device/K940942
Methodology: https://510kreport.com/methodology