FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNERGY ODM
K Number: K132667
·
Decision Oct 9, 2013
Classifications
1
FEI Numbers
31
Registration Numbers
32
Same Product Code
51
Applicant Total
11
Review Days
43
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Basic Information
- Device Name
- SYNERGY ODM
- K Number
- K132667
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Topcon Medical Systems, Inc.
- Date Received
- August 27, 2013
- Decision Date
- October 9, 2013
- Product Code
- NFJ
- Advisory Committee
- Radiology
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| NFJ | System, Image Management, Ophthalmic | FDA class 2 | Radiology |
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Other Clearances by Topcon Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K182376 | Harmony | Sep 28, 2018 | Substantially Equivalent |
| K151952 | Synergy ODM | Oct 1, 2015 | Substantially Equivalent |
| K132438 | IMAGENET 5 PC SOFTWARE SYSTEM | Oct 17, 2013 | Substantially Equivalent |
| K123101 | TRC-50DX RETINAL CAMERA | Jun 5, 2013 | Substantially Equivalent |
| K123460 | TRC-NW300 NON-MYDRIATIC RETINAL CAMERA | Feb 6, 2013 | Substantially Equivalent |
| K110489 | SLIT LAMP SL-2G | May 23, 2011 | Substantially Equivalent |
| K093313 | SYNERGY | Dec 2, 2009 | Substantially Equivalent |
| K083316 | 3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM | Mar 13, 2009 | Substantially Equivalent |
| K072971 | TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS | Jan 13, 2009 | Substantially Equivalent |
| K031831 | TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM | Dec 19, 2003 | Substantially Equivalent |