BA-004CC— 510(k) K261170
Substantially EquivalentFujifilm Corporation
FDA 510(k) clearance K261170 for BA-004CC, Substantially Equivalent on 2026-08-12. Applicant: Fujifilm Corporation. Device class: 2.
Summary
Fujifilm's BA-004CC is filed under product code ITX, diagnostic ultrasonic transducers. The name is a model designation, and the record has no other description.
Class II, 21 CFR 892.1570. Radiology is both the classification panel and the review panel, and it was a Traditional 510(k).
Fujifilm filed from Ashigara Kami-Gun, Japan. The decision came 125 calendar days after FDA received it (April 9 to August 12, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Fujifilm Corporation
- Product code
- Product code ITX
- Device class
- Class 2
- Regulation
- 21 CFR 892.1570
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ashigara Kami-Gun, JP
Recent devices under product code ITX
view allMore clearances from Fujifilm Corporation
view allAdverse events under product code ITX
product code ITX- Death
- 6
- Injury
- 137
- Malfunction
- 2,036
- Total
- 2,179
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.