FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)
K Number: K231666
·
Decision Dec 13, 2023
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
13
Review Days
189
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
- Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)
- K Number
- K231666
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- FUJIFILM Healthcare Americas Corporation
- Date Received
- June 7, 2023
- Decision Date
- December 13, 2023
- Product Code
- ITX
- 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 |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ITX), ordered by most recent decision date.
ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)
FDA 510(k)
FDA Class 2
·Radiology
ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)
FDA 510(k)
FDA Class 2
·Radiology
Mendaera Guidance System
FDA 510(k)
FDA Class 2
·Radiology
Accuro® 3S Needle Guide Kit
FDA 510(k)
FDA Class 2
·Radiology
Ultrasound Transducer Cover
FDA 510(k)
FDA Class 2
·Radiology
UltraDrape UGPIV Barrier and Securement (34-15)
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by FUJIFILM Healthcare Americas Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K261713 | Synapse PACS (7.6.0) | Jun 18, 2026 | Substantially Equivalent |
| K251204 | FUJIFILM Stiffening Wire Device (SW-2000) | Sep 26, 2025 | Substantially Equivalent |
| K243647 | Synapse PACS (7.5) | Jun 30, 2025 | Substantially Equivalent |
| K233321 | Double Balloon Endoscope EN-840T, Over-tube TS-1214C | Jun 13, 2024 | Substantially Equivalent |
| K233629 | APERTO Lucent MRI System | May 10, 2024 | Substantially Equivalent |
| K233687 | ECHELON Synergy V10.0 | May 3, 2024 | Substantially Equivalent |
| K233583 | FCT iSTREAM Phase 1 | Apr 26, 2024 | Substantially Equivalent |
| K240075 | FUJIFILM Endoscope Model EB-710XT | Feb 7, 2024 | Substantially Equivalent |
| K231941 | ARIETTA x10 | Nov 20, 2023 | Substantially Equivalent |
| K231574 | Scenaria View 4.2 | Oct 12, 2023 | Substantially Equivalent |