Atlas FDA

MQB

424 FDA 510(k) clearances · Product code

56 daysmedian time to decision
179 days90th percentile
424clearances measured

FDA profile

Official device name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1680
Medical specialty
Radiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2019: 45 · 2021: 26 · 2022: 13 · 2023: 51 · 2024: 91 · 2025: 142
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
0909FCE, 0909FCE-HS (K253800)Rayence Co., Ltd.2026-07-31
VIVIX-S 4386W (FXRD-4386WA) (K260820)Vieworks Co., Ltd.2026-06-18
Universal 1417PI (K252996)Konica Minolta Healthcare Americas, Inc.2026-06-12
Lux HD 2530 detector (Lux HD 2530) (K252911)Iray Imaging Technology (Haining) Limited2025-10-09
Yushan X-Ray Flat Panel Detector (K250211)Innocare Optoelectronics Corp.2025-07-22
SKR 3000 (K250665)Konica Minolta, Inc.2025-06-17
Wireless/ Wired X-Ray Flat Panel Detectors (K243734)Allengers Medical Systems Limited2025-04-18
EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG (K242770)DRTECH Corporation2025-03-20
EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP (K243443)DRTECH Corporation2025-03-19
Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) (K243556)Iray Imaging Technology (Haining) Limited2025-03-18
ExamVue Apex (K244010)Jpi Healthcare Co, Ltd.2025-02-24
Yushan X-Ray Flat Panel Detector (K243171)Innocare Optoelectronics Corp.2024-12-19
SKR 3000 (K241319)Konica Minolta, Inc.2024-11-21
VIVIX-S 1751S (K241125)Vieworks Co., Ltd.2024-11-15
PRORAD X-Ray Flat Panel Detector with DROC (K240771)Prognosys Medical Systems Private Limited2024-11-12
IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) (K241346)Aspen Imaging Healthcare, Inc.2024-11-07
Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) (K242394)Rayence Co., Ltd.2024-09-09
0909FCC, 0909FCC-HS (K240371)Rayence Co., Ltd.2024-03-07
EXPD 4343S (K232082)DRTECH Corporation2024-02-13
EXPD 4343D; EXPD 3643D (K232753)DRTECH Corporation2023-11-16
MasterX 800 Series (K230918)Medicatech USA2023-09-01
YosemiteView 4343W/YosemiteView 3643W (K232058)Careray Digital Medical Technology Co., Ltd.2023-08-03
EXPD 4357; EXPD 4357P (K231959)DRTECH Corporation2023-08-01
AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 (K231709)Radmedix, LLC2023-07-12
1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF (K231467)Rayence Co., Ltd.2023-06-21
A1417MCW/A1717MCW/F1417MCW (K223930)H&abyz Co., Ltd.2023-03-06
Digital Radiography CXDI-CS01 (K230175)Canon, Inc.2023-02-15
Digital Flat Panel Detector (K230059)Ray Imaging Technology (Haining) Limited2023-02-03
14HQ721G-B (K223546)Lg Electronics.Inc2023-01-27
X-ray Flat Panel Detectors (EverestView 4343X) (K223687)Careray Digital Medical Technology Co., Ltd.2022-12-30
Wireless/Wired X-Ray Flat Panel Detectors (K223009)Allengers Medical Systems Limited2022-11-27
EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG (K223124)DRTECH Corporation2022-11-18
SKR 3000 (K223267)Konica Minolta, Inc.2022-11-17
Mercu 1717V (K222886)Iray Technology Taicang , Ltd.2022-10-20
Digital Radiography CXDI-Pro, Digital Radiography D1 (K222855)Canon, Inc.2022-10-17
Digital Radiography CXDI-Elite, Digital Radiography E1 (K222687)Canon, Inc.2022-09-29
Digital Radiography CXDI-CS01 (K222661)Canon, Inc.2022-09-27
Solid State X-ray Imager(Model: FXRD-4386WB) (K220239)Vieworks Co., Ltd.2022-09-13
X-ray Flat Panel Detectors (CareView 1800 RF) (K221549)Careray Digital Medical Technology Co., Ltd.2022-08-01
10HQ701G-B (K221461)Lg Electronics.Inc2022-07-22
14HQ701G-B (K221394)Lg Electronics.Inc2022-07-22
Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) (K221512)Vieworks Co., Ltd.2022-07-20
Digital Radiography CXDI-Pro, Digital Radiography D1 (K221876)Canon, Inc.2022-07-15
17HQ701G-B (K221434)Lg Electronics.Inc2022-07-13
Flat Panel Detector (K221714)Iray Technology Taicang , Ltd.2022-06-29
Wireless Digital Flat Panel Detector (K221345)Iray Technology Taicang , Ltd.2022-06-16
Digital Radiography CXDI-Elite, Digital Radiography E1 (K221620)Canon, Inc.2022-06-14
PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG (K221144)Radisen Co., Ltd.2022-05-13
17HQ901G-B (K220559)Lg Electronics.Inc2022-05-05
Digital flat panel detector (K220536)Iray Technology Taicang , Ltd.2022-04-28
Yushan X-Ray Flat Panel Detector with DROC (K220510)Innocare Optoelectronics Corp.2022-04-14
Wireless Digital Flat Panel Detector (K220668)Iray Technology Taicang , Ltd.2022-04-01
Focus HD 43 Detector (K213529)Iray Technology Taicang , Ltd.2022-03-29
Focus HD 35 Detector (K213646)Iray Technology Taicang , Ltd.2022-03-29
14HQ901G-B (K214044)Lg Electronics.Inc2022-02-16
Digital Radiography CXDI-Pro, Digital Radiography D1 (K220098)Canon, Inc.2022-02-04
SKR 3000 (K213908)Konica Minolta, Inc.2022-01-31
DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1 (K213780)Canon, Inc.2022-01-24
Universal DR 1748 (K214030)Konica Minolta Healthcare Americas, Inc.2022-01-21
Eclipse II with Smart Noise Cancellation (K213307)Carestream Health, Inc.2022-01-14
VALORY (K213469)Agfa N.V.2021-11-18
ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) (K213497)H&abyz Co., Ltd.2021-11-15
0909FCB, 1212FCA (K212753)Rayence Co., Ltd.2021-10-18
Intelligent NR (K212269)Canon, Inc.2021-09-17
DIGITAL RADIOGRAPHY CXDI-Pro, D1 (K212553)Canon, Inc.2021-09-09
RFA-1717DIG, RFA-1717DIC (K212051)Astel, Inc.2021-08-25
SKR 3000 (K210619)Konica Minolta, Inc.2021-08-24
6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF (K212105)Pzmedical Technology Co., Ltd.2021-08-23
DX-D Imaging Package with XD Detectors (K211790)Agfa N.V.2021-07-30
PRIMO S (K211542)A.T.S. Applicazione Tecnologie Speciali S.R.L.2021-07-09
Prudent 1717, Prudent 1417, Prudent 1212 (K211108)Pixxgen Corporation2021-06-04
AcuityDRe (K210919)Radmedix, LLC2021-04-30
1717FCC (K210985)Rayence Co., Ltd.2021-04-28
Yushan X-Ray Flat Panel Detector with DROC (K210988)Innocare Optoelectronics Corp.2021-04-21
Eclipse II with Smart Noise Cancellation (K202441)Carestream Health, Inc.2021-04-02
I-Q View (K203703)First Source, Inc.2021-03-24
ADD (K203188)H&abyz Co., Ltd.2021-03-12
Mars 1417X Wireless Digital Flat Panel Detector (K210316)Iray Technology Taicang , Ltd.2021-03-03
Mars1717X Wireless Digital Flat Panel Detector (K210314)Iray Technology Taicang , Ltd.2021-03-02
X-ray Flat Panel Detectors/CareView 3600RF (K202995)Careray Digital Medical System Co., Ltd.2021-02-19
General Radiography CXDI-CS01 (K203849)Canon, Inc.2021-01-26
Lux 35 Detector (K203159)Carestream Health2020-12-02
1212FCA (K202722)Rayence Co., Ltd.2020-10-26
Yushan X-Ray Flat Panel Detector with DROC (K201528)Innocare Optoelectronics Corp.2020-10-11
DigitalDiagnost C90 (K202564)Philips Medical Systems Dmc GmbH2020-09-30
Flat Panel Detector (K201591)Ka Imaging, Inc.2020-09-03
X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) (K201932)Careray Digital Medical System Co., Ltd.2020-08-07
1717SCV, 1717SGV (K201796)Rayence Co., Ltd.2020-07-23
Edge Air(1417) Digital Flat Panel X-ray Detector (K201503)Osko, Inc.2020-06-29
Intraoral Sensor (K201247)Dentium Co., Ltd (Ict Branch)2020-06-10
Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) (K201043)Iray Technology Taicang , Ltd.2020-05-12
Accuvue+ (K201058)Radmedix, LLC2020-05-06
Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W (K201004)Iray Technology Taicang , Ltd.2020-05-01
BSD3543W (K200787)Bontech Co., Ltd.2020-04-23
DR-ID 1200SDK System (K200668)Fujifilm Corporation2020-04-10
Focus 43C detector, TRIMAX 43C detector (K200622)Iray Technology Taicang , Ltd.2020-04-01
VIVIX-S VW (K200418)Vieworks Co., Ltd.2020-03-18
Vita Flex CR System with LLI (K192894)Carestream Health, Inc.2020-02-18
E-COM DR-2000 DR (K193644)Livermoretech, Inc.2020-02-14
HAD1717MC (K200018)H&Abyz2020-01-31
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