FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Veraview X800
K Number: K171012
·
Decision Dec 19, 2017
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
133
Applicant Total
52
Review Days
259
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
- Veraview X800
- K Number
- K171012
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- J. Morita USA, Inc.
- Date Received
- April 4, 2017
- Decision Date
- December 19, 2017
- Product Code
- OAS
- 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 |
|---|---|---|---|
| OAS | X-Ray, Tomography, Computed, Dental | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OAS), ordered by most recent decision date.
Dental X-ray System
FDA 510(k)
FDA Class 2
·Radiology
Dental Cone Beam Computed Tomography System
FDA 510(k)
FDA Class 2
·Radiology
medXion NEXUS
FDA 510(k)
FDA Class 2
·Radiology
RCT800
FDA 510(k)
FDA Class 2
·Radiology
Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)
FDA 510(k)
FDA Class 2
·Radiology
myray ProXIma X6
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 |
| 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 |
| K091065 | AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4 | Oct 16, 2009 | Substantially Equivalent |