FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
Ultrasound Scanner System bk2300
K Number: K180737
·
Decision Aug 1, 2018
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
1171
Applicant Total
9
Review Days
132
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Ultrasound Scanner System bk2300
- K Number
- K180737
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bk Medical Aps
- Date Received
- March 22, 2018
- Decision Date
- August 1, 2018
- Product Code
- IYN
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IYN), ordered by most recent decision date.
ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
ES-Series
FDA 510(k)
FDA Class 2
·Radiology
EPIQ Series Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
FDA 510(k)
FDA Class 2
·Radiology
LOGIQ e
FDA 510(k)
FDA Class 2
·Radiology
SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Bk Medical Aps
| K Number | Device Name | ||
|---|---|---|---|
| K231764 | Ultrasound System 1300 | Oct 23, 2023 | Substantially Equivalent |
| K223830 | Ultrasound System 2300 | Apr 11, 2023 | Substantially Equivalent |
| K222441 | Ultrasound System 2300 | Dec 7, 2022 | Substantially Equivalent |
| K173569 | Ultrasound System 1300 | Feb 23, 2018 | Substantially Equivalent |
| K161960 | bk2300 | Oct 17, 2016 | Substantially Equivalent |
| K151910 | Ultrasound Scanner System BK2300 | Oct 5, 2015 | Substantially Equivalent |
| K152052 | Ultrasound Scanner System bk2300 | Sep 16, 2015 | Substantially Equivalent |
| K143298 | Ultrasound Scanner System bk2300 | Jan 16, 2015 | Substantially Equivalent |