FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
I-DIXEL
K Number: K073704
·
Decision Feb 21, 2008
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
52
Review Days
52
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
- I-DIXEL
- K Number
- K073704
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- J. Morita USA, Inc.
- Date Received
- December 31, 2007
- Decision Date
- February 21, 2008
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LLZ), ordered by most recent decision date.
2D Hip Planning Software
FDA 510(k)
FDA Class 2
·Radiology
CustoMED Viewer
FDA 510(k)
FDA Class 2
·Radiology
Helion Viewer Suite
FDA 510(k)
FDA Class 2
·Radiology
CMN Capillary Function with Virtual Expert for MRI, CT and CBCT
FDA 510(k)
FDA Class 2
·Radiology
SubtleHD-PET (1.x)
FDA 510(k)
FDA Class 2
·Radiology
HipGuide (V 1.0.0.0)
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by J. Morita USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K213477 | Root ZX3 | Aug 3, 2022 | Substantially Equivalent |
| K201378 | 3D Accuitomo 150N | Feb 18, 2021 | Substantially Equivalent |
| K190509 | Lubrina 2 | Mar 4, 2020 | Substantially Equivalent |
| K173920 | LS OIL | Oct 11, 2018 | Substantially Equivalent |
| K171012 | Veraview X800 | Dec 19, 2017 | Substantially Equivalent |
| K170275 | Tri Auto ZX2 | Sep 11, 2017 | Substantially Equivalent |
| K120377 | ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A | Jul 25, 2012 | Substantially Equivalent |
| K112665 | TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE | May 4, 2012 | Substantially Equivalent |
| K103697 | TORQTECH | Jan 20, 2012 | Substantially Equivalent |
| K090925 | MULTIPLE (APEX LOCATOR), MODEL RCM-7 | Nov 23, 2009 | Substantially Equivalent |