FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS
K Number: K072971
·
Decision Jan 13, 2009
Classifications
1
FEI Numbers
29
Registration Numbers
30
Same Product Code
65
Applicant Total
11
Review Days
449
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
- TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS
- K Number
- K072971
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1570
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Topcon Medical Systems, Inc.
- Date Received
- October 22, 2007
- Decision Date
- January 13, 2009
- Product Code
- OBO
- Advisory Committee
- Ophthalmic
- 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 |
|---|---|---|---|
| OBO | Tomography, Optical Coherence | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OBO), ordered by most recent decision date.
SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module
FDA 510(k)
FDA Class 2
·Ophthalmic
UNITY DX (UDX)
FDA 510(k)
FDA Class 2
·Ophthalmic
Tomey Cornea/Anterior Segment OCT (CASIA2)
FDA 510(k)
FDA Class 2
·Ophthalmic
SPECTRALIS HRA+OCT and variants
FDA 510(k)
FDA Class 2
·Ophthalmic
Anterion
FDA 510(k)
FDA Class 2
·Ophthalmic
SPECTRALIS with Flex Module
FDA 510(k)
FDA Class 2
·Ophthalmic
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 |
| K132667 | SYNERGY ODM | Oct 9, 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 |
| K031831 | TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM | Dec 19, 2003 | Substantially Equivalent |