Atlas FDA

Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter

FDA 510(k) clearance K183599 · decided 2019-04-12

Clearance details

K-number
K183599
Device name
Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter
Applicant
Infraredx, Inc.
Decision
Substantially Equivalent
Date received
2018-12-26
Decision date
2019-04-12
Days to decision
107 days
Clearance type
Traditional
Product code
OGZ
Device class
2
Regulation number
870.1200
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Burlington, MA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 ) (K241576)Infraredx, Inc.2025-02-26
TVC Imaging System, TVC Catheter (K163345)Infraredx, Inc.2017-06-21
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER (K141682)Infraredx, Inc.2014-11-24
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER (K133897)Infraredx, Inc.2014-04-23
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER (K130719)Infraredx, Inc.2013-10-17
TVC IMAGING SYSTEM MODEL NIRS-MC7-70 (K123108)Infraredx, Inc.2013-03-15
LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70 (K093993)Infraredx, Inc.2010-06-30
INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 (K072932)Infraredx, Inc.2008-04-25

Recalls involving this device

No recalls on record reference this clearance.