510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Rayence Co., Ltd.

Hwaseong-si Gyeonggi, KR

RAYENCE CO., LTD. appears in FDA device records in Hwaseong-si Gyeonggi, KR. FDA records list 39 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
39
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 39 510(k) clearances for Rayence Co., Ltd. between 2011 and 2026. The busiest year on record is 2014, with 6. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Rayence Co., Ltd., by decision year
YearClearances
20111
20122
20135
20146
20155
20163
20174
20192
20202
20213
20221
20231
20242
20251
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K2538000909FCE, 0909FCE-HSMQBSubstantially Equivalent
K2438492430TCA with Xmaru WMUESubstantially Equivalent
K242394Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)MQBSubstantially Equivalent
K2403710909FCC, 0909FCC-HSMQBSubstantially Equivalent
K2314671417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GFMQBSubstantially Equivalent
K220689Vatech ClismileNJMSubstantially Equivalent
K2127530909FCB, 1212FCAMQBSubstantially Equivalent
K2029022430MCA with Xmaru WMUESubstantially Equivalent
K2109851717FCCMQBSubstantially Equivalent
K2027221212FCAMQBSubstantially Equivalent
K2017961717SCV, 1717SGVMQBSubstantially Equivalent
K190866XmaruView V1 (Xmaru Chiroview, Xmaru Podview)LLZSubstantially Equivalent
K183478ClearON MobileLLZSubstantially Equivalent
K1714181417WCC_127um and1417WCC_140umMQBSubstantially Equivalent
K1714171417WGC_127um and 1417WGC_140umMQBSubstantially Equivalent
K1714201717SCC_127um and 1717SCC_140umMQBSubstantially Equivalent
K1714191717SGC_127um and 1717SGC_140umMQBSubstantially Equivalent
K1625191717WCC / 1717WGCMQBSubstantially Equivalent
K1625181012WCC, 1012WGCMQBSubstantially Equivalent
K160579Xmaru View V1 and Xmaru PACS, Medical Image Processing SoftwareLLZSubstantially Equivalent
K153060Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-SMUHSubstantially Equivalent
K151707EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio iMUHSubstantially Equivalent
K150797Digital Dental Intra Oral Sensor, EzSensor SmartMUHSubstantially Equivalent
K1501501717SGN / 1717SCN Digital Flat Panel X-ray DetectorMQBSubstantially Equivalent
K143753Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor BioMUHSubstantially Equivalent
K141566SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCCMQBSubstantially Equivalent
K141563SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGCMQBSubstantially Equivalent
K140060DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000AMQBSubstantially Equivalent
K140056DIGITAL DENTAL INTRA ORAL SENSOR; HDI 1000, HDI 1000AMQBSubstantially Equivalent
K140646DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717GMQBSubstantially Equivalent
K133409DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGAMQBSubstantially Equivalent
K131114DIGITAL FLAT PANEL X-RAY DETECTORMQBSubstantially Equivalent
K130935DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCAMQBSubstantially Equivalent
K123345DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCAMQBSubstantially Equivalent
K122928DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGAMQBSubstantially Equivalent
K122919DIGITAL FLAT PANEL X-RAY DETECTOR11417PCAMQBSubstantially Equivalent
K122173DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCCMQBSubstantially Equivalent
K122182DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGCMQBSubstantially Equivalent
K113630DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGAMQBSubstantially Equivalent

Registered establishments

FDA registered establishments for Rayence Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30090483843009048384RAYENCE CO., LTD.14,Samsung 1-ro 1-gil & #201, 13, Samsung 1-ro 2-gil, Hwaseong-si Gyeonggi 18449 KR2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain