KODAK DIRECTVIEW CR MAMMOGRAPHY FEATURE
CARESTREAM HEALTH, INC.
Carestream Health, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1317267 | 1317267 | Carestream Health, Inc. | 1 | N | 2026-01-01 | 1669 Lake Avenue Rochester NY US 14652 |
| 3029911 | 1000524463 | Carestream Health, Inc. | 1 | Y | 2026-01-01 | 8124 Pacific Ave WHITE CITY OR US 97503 |
| 3015532525 | 3015532525 | CARESTREAM HEALTH, INC. | 1 | Y | 2026-01-01 | 882 Linden Ave. Rochester NY US 14625 |
| 1718432 | 1718432 | Carestream Health, Inc. | 1 | Y | 2020-04-25 | 2000 Howard Smith Avenue West Windsor CO US 80550 |
| 2133929 | 3002095347 | CARESTREAM HEALTH, INC. | 1 | Y | 2020-04-25 | 1 IMATION WAY OAKDALE MN US 55128 |
| 3006450624 | 3006450624 | CARESTREAM HEALTH, INC. | 1 | Y | 2020-04-25 | 1600 Lexington Ave Rochester NY US 14652 |
| 3011681986 | 3011681986 | Carestream Health, Inc. | 1 | N | 2020-04-25 | 5450 Campus Drive Canandaigua NY US 14424 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 67825 | 1190362892 | K972163 | IMATION SE-196 LASER IMAGER | LMC | 1997-09-05 |
| 148382 | 2067410852 | K192292 | L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable | OWN | 2019-11-19 |
| 148382 | 1287627554 | K192174 | SPY Portable Handheld Imaging (SPY-PHI) System | OWN | 2019-11-15 |
| 148382 | 1337246634 | K191046 | L10 LED Light Source with AIM, L11 LED Light Source with AIM | OWN | 2019-05-10 |
| 148382 | 1938799129 | K182907 | SPY Elite Intraoperative Perfusion Assessment System | IZI | 2019-01-23 |
| 148382 | 1270811341 | K182606 | PINPOINT Endoscopic Fluorescence Imaging System | GCJ | 2018-11-21 |
| 184696 | 1837579856 | K153142 | Carestream DRX-1 System with DRX Plus 4343 Detectors | MQB | 2015-11-25 |
| 184696 | 1541696230 | K150766 | Carestream DRX-1 System | MQB | 2015-06-24 |
| 184696 | 1097380521 | K130464 | CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR | MQB | 2013-06-07 |
| 148382 | 1395275629 | K123013 | ENDOSCOPIC INTRODUCER | FED | 2013-03-22 |
| 67825 | 1817585049 | K090469 | CARESTREAM DRYVIEW 5850 LASER IMAGER | LMC | 2009-05-22 |
| 148382 | 1167462388 | K071619 | SPY FLUORESCENT IMAGING SYSTEM | IZI | 2007-11-09 |
| 148382 | 1572032432 | K071037 | SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000 | IZI | 2007-05-10 |
| 67817 | 1917934637 | ||||
| 67825 | 1917934637 | ||||
| 67825 | 2062245003 | ||||
| 67825 | 2063292547 | ||||
| 67823 | 2063292547 | ||||
| 234948 | 1270811341 | ||||
| 234948 | 1287627554 | ||||
| 234948 | 1337246634 | ||||
| 67823 | 1917934637 | ||||
| 67818 | 1917934637 | ||||
| 234948 | 1938799129 | ||||
| 234948 | 2067410852 |
Product Codes Associated With Registrations#
PMA#
KODAK DIRECTVIEW COMPUTED RADIOGRAPHY (CR) MAMMOGRAPHY
CARESTREAM HEALTH, INC.
PMN#
DRX-Revolution Mobile X-ray System
Carestream Health, Inc.
DRX-Evolution Plus System
Carestream Health, Inc.
DRX - Compass
Carestream Health, Inc.
Eclipse II With Smart Noise Cancellation
Carestream Health, Inc.
Eclipse II With Smart Noise Cancellation
Carestream Health, Inc.
Vita Flex CR System With LLI
Carestream Health, Inc.
Q-Rad System
Carestream Health, Inc.
DRX-Evolution With Carestream Digital Tomosynthesis
Carestream Health, Inc.
DRX-Evolution/Plus With Dual Energy
Carestream Health, Inc.
Carestream DRX-1 System With DRX Plus 2530 Detectors
Carestream Health, Inc.
Carestream DRX-1 System With DRX Core Detectors
Carestream Health, Inc.
SmartGrid
Carestream Health, Inc.
DRX-Revolution Nano Mobile X-ray System
Carestream Health, Inc.
OnSight 3D Extremity System
Carestream Health, Inc.
DRX-Revolution Nano Mobile X-ray System
Carestream Health, Inc.
Carestream Vue PACS
Carestream Health, Inc.
Carestream DRX-Evolution
Carestream Health, Inc.
OnSight 3D Extremity System
CARESTREAM HEALTH, INC.
CARESTREAM Vue PACS
CARESTREAM HEALTH, INC.
Touch Ultrasound
CARESTREAM HEALTH, INC.
Carestream DRX-1 System With DRX Plus 4343 Detectors
CARESTREAM HEALTH, INC.
CARESTREAM Vue Motion
CARESTREAM HEALTH, INC.
Carestream DRX-1 System
Carestream Health, Inc.
Touch Ultrasound
CARESTREAM HEALTH, INC.
TABLET VIEWER SOFTWARE FOR IMAGE SUITE
CARESTREAM HEALTH, INC.
BONE SUPPRESSION SOFTWARE
CARESTREAM HEALTH, INC.
DR LONG LENGTH IMAGING SOFTWARE
CARESTREAM HEALTH, INC.
CARESTREAM VUE PACS
CARESTREAM HEALTH, INC.
DRX-REVOLUTION MOBILE X-RAY SYSTEM
CARESTREAM HEALTH, INC.
CARESTREAM PACS
CARESTREAM HEALTH, INC.
CS 7600
CARESTREAM HEALTH, INC.
KODAK 1500 INTRAORAL CAMERA
CARESTREAM HEALTH, INC.
DRX-EVOLUTION, MODEL VX3733-SYS
CARESTREAM HEALTH, INC.
CARESTREAM DRYVIEW 5850 LASER IMAGER
CARESTREAM HEALTH, INC.
CARESTREAM DRX-1 SYSTEM
CARESTREAM HEALTH, INC.
CARESTREAM PACS, MODEL CARESTREAM PACS VII
CARESTREAM HEALTH, INC.
GUDID#
CARESTREAM Image Suite - IMAGESUITE CONSOLE SW
2022-02-25
Vue Cardio PACS - CARDIO PACS SERVER SW <10K/ MED VOL
2016-09-16
DRX - Ascend System - LONG LENGTH IMAGING SW FOR DRX-ASCEND
2017-07-24
Vue PACS - PACS WFM SW < 25K EXAMS/YR
2016-09-16
Vue PACS - UNLIMITED READING LIC < 25K EX/YR
2016-09-16
Vue Motion - VUE MOTION UNLIMITED SW < 50K EX/YR
2016-09-16
CARESTREAM Image Suite - IMAGE SUITE / V4 SW MEDICAL APP
2016-09-16
DRX-Compass X-ray System - X-RAY SYSTEM CONSOLE PDU 3 P 380-480 C/F
2022-01-11
DRX-Evolution Plus System - DRX-Evolution Plus Automatic - Dual Buck
2016-09-16
DRX-Revolution Mobile X-ray System - DRX-MOBILE CONSOLE
2016-09-16
CARESTREAM DRX-EVOLUTION - ASSM-UNIVERSAL GRID HOLDER, DRX-EVOLUTIO
2016-09-16
CS 7200 - Hygienic Sheaths #1 - 200 Pcs
2016-09-16
CS 7200 - Hygienic Sheaths #2 - 200 Pcs
2016-09-16
CS 7400 - CR SEMI-FIN PLATE PAN V2 15X30CM
2016-09-16
CS 7400 - CR SEMI-FIN PLATE PAN V2 5X12IN
2016-09-16
CS 7400 - CR SEMI-FIN PLATE PAN 15X30CM
2016-09-16
CS 7400 - CR SEMI-FIN PLATE PAN 5X12IN
2016-09-16
Vita Flex CR System - VITA FLEX CR SYSTEM 60PPH
2019-08-03
Vita Flex CR System - VITA FLEX CR SYSTEM 60PPH WITH PC&MONITO
2019-08-03
Vita Flex CR System - VITA FLEX CR SYSTEM, NB 60PPH WITH PC&MO
2019-08-03
Vita Flex CR Long Length Imaging System - VITA FLEX CR LLI KIT
2020-05-25
VITA LE CR SYSTEM
2016-09-16
CS 7600 - CS 7600 INTRAORAL IMAGING PLATE SYS
2016-09-16
CS 7600 - CS 7600 SCAN&GO DEVICE
2016-09-16
CS 7600 SLOT PANEL - CS 7600 SLOT PANEL SIZE 1-3
2016-09-16
CS 7600 SLOT PANEL - CS 7600 SLOT PANEL SIZE 4
2016-09-16
Vita CR System - VITA V3.2 LITE SOFTWARE
2016-10-03
VITA XE CR SYSTEM
2016-09-16
Vita XE CR System - NON BRANDED VITA XE CR SYSTEM
2016-09-16
CS 7600 SLOT PANEL - CS 7600 SLOT PANEL SIZE 0 ONLY
2016-09-16
Vita LE CR System - VITA LE CR SOLUTION W / PC AND MONITOR
2016-09-16
Max CR system
2016-09-16
Vita Flex CR System - Vita Flex CR System 30PPH
2017-06-09
CS 7200 - CS 7200 Imaging Plate System
2016-09-16
Vita XE CR System - NB VITA XE CR SOLUTION W / COMPUTER
2016-09-16
Vita CR System - NB VITA CR SOLUTION W / COMPUTER
2016-09-16
Vita LE CR System - NB VITA LE CR SOLUTION W / COMPUTER
2016-09-16
CS 7600 - CS7600 Imaging System for US, CA, Brazil
2016-09-16
Vita Flex CR System - Vita Flex CR System 45PPH
2016-09-16
Vita Flex CR System - Vita Flex CR 30PPH solution PC/Monitor
2016-09-16