FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5
K Number: K052908
·
Decision Jun 23, 2006
Classifications
1
FEI Numbers
210
Registration Numbers
211
Same Product Code
499
Applicant Total
11
Review Days
252
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Basic Information
- Device Name
- INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5
- K Number
- K052908
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Infraredx, Inc.
- Date Received
- October 14, 2005
- Decision Date
- June 23, 2006
- Product Code
- DQO
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQO), ordered by most recent decision date.
Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N
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Other Clearances by Infraredx, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K241576 | Makoto Intravascular Imaging System (VC-MC10 / TVC-MC10i); Dualpro IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 ) | Feb 26, 2025 | Substantially Equivalent |
| K213303 | Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42 | Dec 7, 2021 | Substantially Equivalent |
| K183599 | Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter | Apr 12, 2019 | Substantially Equivalent |
| K163345 | TVC Imaging System, TVC Catheter | Jun 21, 2017 | Substantially Equivalent |
| K141682 | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | Nov 24, 2014 | Substantially Equivalent |
| K133897 | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | Apr 23, 2014 | Substantially Equivalent |
| K130719 | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | Oct 17, 2013 | Substantially Equivalent |
| K123108 | TVC IMAGING SYSTEM MODEL NIRS-MC7-70 | Mar 15, 2013 | Substantially Equivalent |
| K093993 | LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70 | Jun 30, 2010 | Substantially Equivalent |
| K072932 | INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 | Apr 25, 2008 | Substantially Equivalent |