invivocorp.comInvivo - 3T FlexiLoc Set
2016-09-23
Philips DS North America LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3023385454 | 3023385454 | Philips DS North America LLC | 1 | Y | 2026-01-01 | 3630 SW 47th Avenue Gainesville FL US 32608 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00884838072657 | Invivo - 3T FlexiLoc Set | +1(877)468-4861 | dynasupport@invivocorp.com |
| 00884838072664 | Invivo - 3T ClipLoc Set | +1(877)468-4861 | dynasupport@invivocorp.com |
| 00884838072756 | Invivo - LeLoc Double Hook Wire Loc. Needle | +1(877)468-4861 | dynasupport@invivocorp.com |
| 00884838072763 | Invivo - LeLoc Double Hook Wire Loc. Needle | +1(877)468-4861 | dynasupport@invivocorp.com |
| 00884838072770 | Invivo - FlexiLoc Localization Needle | +1(877)468-4861 | dynasupport@invivocorp.com |
| 00884838072787 | Invivo - FlexiLoc Localization Needle | +1(877)468-4861 | dynasupport@invivocorp.com |
| 00884838072794 | Invivo - ClipLoc Localization Needle | +1(877)468-4861 | dynasupport@invivocorp.com |
| 00884838072800 | Invivo - ClipLoc Localization Needle | +1(877)468-4861 | dynasupport@invivocorp.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 304986 | 1305962650 | K250800 | UroNav 4 | LLZ | 2025-06-05 |
| 304986 | 1237491211 | K212175 | DynaCAD | LLZ | 2021-08-02 |
| 304986 | 1498322000 | K193403 | UroNav System | LLZ | 2019-12-27 |
| 304986 | 1945870490 | K192200 | DynaCAD | LLZ | 2019-10-09 |
| 304986 | 1612383257 | K182561 | UroNav (Version 3.0) | LLZ | 2018-10-19 |
| 304986 | 1705222435 | K153073 | UroNav (Version 2.0) | LLZ | 2015-11-16 |
| 304986 | 1509585163 | K133030 | DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE) | LLZ | 2014-01-22 |
| 304986 | 1938202800 | K121517 | VERSAVUE ENTERPRISE SUITE | LLZ | 2012-07-20 |
| 304986 | 1847618035 | K023130 | ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEM | LNH | 2002-10-11 |
| 304986 | 1577376755 |
Product Codes Associated With Registrations#
GUDID#
Invivo - 3T ClipLoc Set
2016-09-23
Invivo - LeLoc Double Hook Wire Loc. Needle
2016-09-23
Invivo - LeLoc Double Hook Wire Loc. Needle
2016-09-23
Invivo - FlexiLoc Localization Needle
2016-09-23
Invivo - FlexiLoc Localization Needle
2016-09-23
Invivo - ClipLoc Localization Needle
2016-09-23
Invivo - ClipLoc Localization Needle
2016-09-23
Invivo - ClipLoc Localization Needle
2016-09-23
Invivo - Baseplate Assembly, Prostate, GE
2020-04-17
Invivo - UroNAV 1.x to 2.0 Upgrade
2016-09-23
Invivo - Fully Automatic Biopsy Gun
2016-09-23
Invivo - Fully Automatic Biopsy Gun
2016-09-23
Invivo - Fully Automatic Biopsy Gun
2016-09-23
Invivo - Fully Automatic Biopsy Gun
2016-09-23
Invivo - Fully Automatic Biopsy Gun
2016-09-23
Invivo - UroNAV Fusion Biopsy System
2016-09-23
Invivo - DynaLoc Prostate 3.5
2017-07-28
Invivo - UroNAV Fusion Biopsy System
2016-09-23
Philips - dS FLEX-S 1.5T
2021-06-11
GE - 16Ch Shoulder Coil 1.5T
2016-09-23
Invivo - Biopsy Grid (User-sterilized)
2016-09-23
MRI Coils - dS Microscopy 23mm, Ingenia 1.5T
2021-10-28
Invivo - SENSE MSK M 8CH 1.5T
2016-09-23
KITS (Disposables) - Needle Block
2016-09-23
KITS (Disposables) - Needle Block
2016-09-23
KITS (Disposables) - Needle Block
2016-09-23
KITS (Disposables) - Needle Sleeve
2016-09-23
Invivo KITS (Disposables) - Pillar Immobilization Plate BBC
2016-09-23
Invivo - Grid Immobilization Plate OBC
2016-09-23
Invivo KITS (Disposables) - Grid Immobilization Plate LBS C-C
2016-09-23
Invivo KITS (Disposables) - Grid Immobilization Plate LBS M-L
2016-09-23
Invivo KITS (Disposables) - Pillar Immobilization Plate LBS C-C
2016-09-23
Invivo KITS (Disposables) - Pillar Immobilization Plate LBS M-L
2016-09-23
Sentinelle - Breast MRI 8ch Tabletop for Siemens 1.5T
2016-09-23
Philips - Breast MRI 16ch Tabletop for Siemens 3T
2016-09-22
KITS (Disposables) - Needle Sleeve
2016-09-23
Invivo KITS (Disposables) - Grid Immobilization Plate BBC
2016-09-23
Invivo KITS (Disposables) - Pillar Immobilization Plate BBC
2016-09-23
Invivo KITS (Disposables) - Needle Block Holder
2016-09-23