{ "code": "MUH", "deviceName": "System, X-Ray, Extraoral Source, Digital", "deviceClass": "II", "regulationNumber": "872.1800", "panel": "Dental", "definition": null, "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 206, "last12Months": 4 }, "adverseEvents": { "total": 2, "last12Months": 0 }, "reviewDays": { "median": 72, "sampleSize": 206 }, "recalls": { "total": 9, "recent": [ { "resNumber": "Z-1387-2019", "status": "Terminated", "recallClass": "Class II", "firm": "KaVo Dental Technologies LLC", "firmAsPublished": "KaVo Dental Technologies LLC", "reason": "The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality.", "initiated": "2019-04-29" }, { "resNumber": "Z-0128-2016", "status": "Terminated", "recallClass": "Class II", "firm": "Villa Radiology Systems LLC", "firmAsPublished": "Villa Radiology Systems LLC", "reason": "It has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and 1020.330).", "initiated": "2015-08-05" }, { "resNumber": "Z-1377-2015", "status": "Terminated", "recallClass": "Class II", "firm": "Carestream Health, Inc.", "firmAsPublished": "Carestream Health, Inc.", "reason": "Units device head descended unexpectedly", "initiated": "2015-01-08" }, { "resNumber": "Z-1378-2015", "status": "Terminated", "recallClass": "Class II", "firm": "Carestream Health, Inc.", "firmAsPublished": "Carestream Health, Inc.", "reason": "Units device head descended unexpectedly", "initiated": "2015-01-08" }, { "resNumber": "Z-0651-2016", "status": "Terminated", "recallClass": "Class II", "firm": "Midmark Corp dba Progeny Inc", "firmAsPublished": "Midmark Corp dba Progeny Inc", "reason": "Failure of the primary collimator may result in unintentional movement of the device. The unintentional movement will not result in the generation of an error message.", "initiated": "2014-09-04" } ] }, "recentClearances": [ { "kNumber": "K251793", "deviceName": "SOTA Cloud Smart Sensor (1.5)", "applicant": "Sota Cloud Corp.", "company": "SOTA CLOUD CORPORATION", "decisionDate": "2026-03-03", "dateReceived": "2025-06-11" }, { "kNumber": "K252570", "deviceName": "EzSensor HD, EzSensor UHD", "applicant": "Qpix Solutions, Inc.", "company": "Qpix Solutions, Inc.", "decisionDate": "2025-11-10", "dateReceived": "2025-08-14" }, { "kNumber": "K250687", "deviceName": "Cocoon Solo (DX-7020s)", "applicant": "Dexcowin Global, Inc.", "company": "Dexcowin Global, Inc.", "decisionDate": "2025-10-24", "dateReceived": "2025-03-06" }, { "kNumber": "K251206", "deviceName": "Digital X-Ray DentiMax Pro Imaging System", "applicant": "Dentimax, Inc.", "company": "Dentimax, Inc.", "decisionDate": "2025-09-24", "dateReceived": "2025-04-18" }, { "kNumber": "K240040", "deviceName": "VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)", "applicant": "VATECH Co., Ltd.", "company": "VATECH Co., Ltd.", "decisionDate": "2024-10-25", "dateReceived": "2024-01-05" }, { "kNumber": "K242778", "deviceName": "X Sensor (Model: IOS-A15IF, HDI-15DGF)", "applicant": "Qpix Solutions, Inc.", "company": "Qpix Solutions, Inc.", "decisionDate": "2024-10-11", "dateReceived": "2024-09-13" }, { "kNumber": "K241649", "deviceName": "DUO1 and DUO2", "applicant": "Zinnovi, Inc.", "company": "Zinnovi, Inc.", "decisionDate": "2024-07-05", "dateReceived": "2024-06-07" }, { "kNumber": "K232325", "deviceName": "RAYSCAN a-Expert", "applicant": "Ray Co., Ltd.", "company": "RAY CO., LTD,", "decisionDate": "2024-04-18", "dateReceived": "2023-08-03" }, { "kNumber": "K231660", "deviceName": "Digital image scanner of dental", "applicant": "Jiangsu Dynamic Medical Technology Co., Ltd.", "company": "Jiangsu Dynamic Medical Technology Co., Ltd.", "decisionDate": "2023-12-20", "dateReceived": "2023-06-07" }, { "kNumber": "K233053", "deviceName": "DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor", "applicant": "Dental Imaging Technologies Corporation", "company": "Dental Imaging Technologies Corporation", "decisionDate": "2023-11-21", "dateReceived": "2023-09-25" } ], "topApplicants": [ { "name": "VATECH Co., Ltd.", "count": 8 }, { "name": "Genoray Co., Ltd.", "count": 7 }, { "name": "Sirona Dental Systems GmbH", "count": 7 }, { "name": "Trophy", "count": 6 }, { "name": "Instrumentarium Dental, Palodex Group OY", "count": 5 } ], "topCompanies": [ { "name": "VATECH Co., Ltd.", "count": 8, "spellings": 1 }, { "name": "Genoray Co., Ltd.", "count": 7, "spellings": 1 }, { "name": "Sirona Dental Systems GmbH", "count": 7, "spellings": 1 }, { "name": "Trophy Sas", "count": 6, "spellings": 1 }, { "name": "Instrumentarium Dental, PaloDEx Group Oy", "count": 5, "spellings": 1 } ], "newEntrants": [ { "name": "SOTA CLOUD CORPORATION", "since": "2026-03-03", "kNumber": "K251793" }, { "name": "Dexcowin Global, Inc.", "since": "2025-10-24", "kNumber": "K250687" } ], "baseline": { "months": [ { "month": "2023-07-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-05-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false } ], "sufficientMonths": 0, "method": null }, "signal": { "summary": "MUH (System, X-Ray, Extraoral Source, Digital) has two findings, most consequential first. 2 first-time filers in the last 12 months, SOTA CLOUD CORPORATION and Dexcowin Global, Inc (K251793, K250687). The code is crowded, scoring 76 of 100 — 111 companies hold a clearance here and 4 arrived in the last 12 months (MUH:crowding).", "severity": 42, "factors": [ { "kind": "new_entrant", "detail": "2 first-time filers in the last 12 months, SOTA CLOUD CORPORATION and Dexcowin Global, Inc.", "recordIds": [ "K251793", "K250687" ], "severity": 42 }, { "kind": "crowding", "detail": "the code is crowded, scoring 76 of 100 — 111 companies hold a clearance here and 4 arrived in the last 12 months", "recordIds": [ "MUH:crowding" ], "severity": 20 } ], "sourcesChecked": [ "predicate ancestry", "recalls", "adverse events", "new entrants", "review time", "crowding" ] }, "predicatePreview": { "edges": [], "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet." }, "sources": [ { "label": "classification", "url": "https://api.fda.gov/device/classification.json?search=product_code%3AMUH" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AMUH" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AMUH" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3AMUH" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AMUH" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AMUH" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AMUH" } ], "provenance": [ { "dataset": "device/510k", "loadedAt": "2026-08-10T19:40:09Z", "ingestRun": 51, "exportDate": "2026-08-08" }, { "dataset": "device/classification", "loadedAt": "2026-08-10T06:54:18Z", "ingestRun": 2, "exportDate": "2026-08-08" }, { "dataset": "device/enforcement", "loadedAt": "2026-08-10T19:40:12Z", "ingestRun": 53, "exportDate": "2026-08-04" }, { "dataset": "device/event", "loadedAt": "2026-08-11T13:49:57Z", "ingestRun": 73, "exportDate": "2026-08-11" }, { "dataset": "device/recall", "loadedAt": "2026-08-10T19:40:11Z", "ingestRun": 52, "exportDate": "2026-08-08" }, { "dataset": "device/registrationlisting", "loadedAt": "2026-08-10T07:06:24Z", "ingestRun": 10, "exportDate": "2026-08-08" } ], "retrievedAt": "2026-08-11T13:51:45.747Z" }