Product code MYN
- Product
- Radiation Emitting Electronic Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical De
- Definition
- Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co
- Description
- Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Radiation Emitting Electronic Product Codes Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_lang', SrcUrl: Unescape('mp_js_orgin_url'), Init: Function(){ If (MP.UrlLang.indexOf('p_js_')==1) { MP.SrcUrl=window.top.document.location.href; MP.UrlLang=MP.SrcLang; } }, GetCookie: Function(name){ Var Start=document.cookie.indexOf(name+'='); If(start < 0) Return Null; Start=start+name.length+1; Var End=document.cookie.indexOf(';', Start); If(end < 0) End=document.cookie.length; While (document.cookie.charAt(start)==' '){ Start++; } Return Unescape(document.cookie.substring(start,end)); }, SetCookie: Function(name,value,path,domain){ Var Cookie=name+'='+escape(value); If(path)cookie+='; Path='+path; If(domain)cookie+='; Domain='+domain; Var Now=new Date(); Now.setTime(now.getTime()+1000*60*60*24*365); Cookie+='; Expires='+now.toUTCString(); Document.cookie=cookie; }, SwitchLanguage: Function(lang){ If(lang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[lang]+'/'+MP.SrcLang+lang+'/?1023749632;'+encodeURIComponent(MP.SrcUrl); Document.body.appendChild(script); } Else If(lang==MP.SrcLang && MP.UrlLang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[MP.UrlLang]+'/'+MP.SrcLang+MP.UrlLang+'/?1023749634;'+encodeURIComponent(location.href); Document.body.appendChild(script); } Return False; }, SwitchToLang: Function(url) { Window.top.location.href=url; } }; Var Addthis_config = {data_track_clickback: True, Ui_508_compliant: True, Services_compact: 'facebook, Twitter, Linkedin, Pinterest_share, Email', Services_exclude: 'print', Image_container: "#user_provided" } ; FDA Home Medical Devices Databases -
- Regulation number
- Radiation type
- Radiation Emitting Electronic Product Codes // Qui
- Applicable standards
- Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Radiation Emitting Electronic Product Codes Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_lang', SrcUrl: Unescape('mp_js_orgin_url'), Init: Function(){ If (MP.UrlLang.indexOf('p_js_')==1) { MP.SrcUrl=window.top.document.location.href; MP.UrlLang=MP.SrcLang; } }, GetCookie: Function(name){ Var Start=document.cookie.indexOf(name+'='); If(start < 0) Return Null; Start=start+name.length+1; Var End=document.cookie.indexOf(';', Start); If(end < 0) End=document.cookie.length; While (document.cookie.charAt(start)==' '){ Start++; } Return Unescape(document.cookie.substring(start,end)); }, SetCookie: Function(name,value,path,domain){ Var Cookie=name+'='+escape(value); If(path)cookie+='; Path='+path; If(domain)cookie+='; Domain='+domain; Var Now=new Date(); Now.setTime(now.getTime()+1000*60*60*24*365); Cookie+='; Expires='+now.toUTCString(); Document.cookie=cookie; }, SwitchLanguage: Function(lang){ If(lang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[lang]+'/'+MP.SrcLang+lang+'/?1023749632;'+encodeURIComponent(MP.SrcUrl); Document.body.appendChild(script); } Else If(lang==MP.SrcLang && MP.UrlLang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[MP.UrlLang]+'/'+MP.SrcLang+MP.UrlLang+'/?1023749634;'+encodeURIComponent(location.href); Document.body.appendChild(script); } Return False; }, SwitchToLang: Function(url) { Window.top.location.href=url; } }; var Addthis_config = {data_track_clickback: True, Ui_508_compliant: True, Services_compact: 'facebook, Twitter, Linkedin, Pinterest_share, Email', Services_exclude: 'print', Image_container: "#user_provided" } ; FDA Home Medical Devices Databases -
Current FDA Classification
- Device name
- Analyzer, Medical Image
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.2070
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- For information on the MYN device, please see: https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers
Related Records
Related PMA Records
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| P980025S003 | LOGICON CARIES DETECTOR | CARESTREAM DENTAL LLC | 2015-12-10 |
| P120004S001 | PARASCRIPT (R) ACCUDETECT (R) | PARASCRIPT, LLC | 2015-10-16 |
| P980025S002 | LOGICON CARIES DETECTOR | CARESTREAM DENTAL LLC | 2014-07-22 |
| P120004 | PARASCRIPT ACCUDETECT 6.1.0 | PARASCRIPT, LLC | 2013-08-22 |
| P010038S017 | SECONDLOOK DIGITAL | ICAD, INC. | 2013-06-19 |
| P010038S013 | SECONDLOOK (SL) CAD | ICAD, INC. | 2010-12-07 |
| P010038S012 | SECONDLOOK COMPUTER-AIDED DETECTION SYSTEM | ICAD, INC. | 2008-04-04 |
| P010038S014 | SECONDLOOK | ICAD, INC. | 2007-07-27 |
| P980025S001 | LOGICON CARIES DETECTOR | CARESTREAM DENTAL LLC | 2007-01-12 |
| P010038S010 | SECOND LOOK | ICAD, INC. | 2006-01-13 |
| P010038S009 | SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM | ICAD, INC. | 2005-03-07 |
| P010038S008 | SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM | ICAD, INC. | 2004-09-01 |
| P010038S006 | ICAD SYSTEM | ICAD, INC. | 2004-05-21 |
| P010038S007 | ICAD SYSTEM | ICAD, INC. | 2004-05-19 |
| P010038S005 | ICAD SYSTEM | ICAD, INC. | 2003-10-31 |
| P010038S003 | ICAD | ICAD, INC. | 2003-03-06 |
| P010038 | SECOND LOOK | ICAD, INC. | 2002-01-15 |
| P980025 | LOGICON CARIES DETECTOR | CARESTREAM DENTAL LLC | 1998-09-25 |
Related 510(k) Records
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| K252953 | Velmeni for Dentists (V4D) Endo-Perio | Velmeni, Inc. | 2026-05-11 |
| K251934 | qXR-Detect | Qure.Ai Technologies | 2026-01-16 |
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| K250753 | VELMENI for DENTISTS (V4D) | Velmeni, Inc. | 2025-09-02 |
| K243234 | Second Opinion® CS | Pearl, Inc. | 2025-06-12 |
| K242437 | Smile Dx® | Cube Click, Inc. | 2025-05-14 |
| K243893 | Second Opinion® Pediatric | Pearl, Inc. | 2025-05-05 |
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| K243831 | Rayvolve LN | AZmed | 2025-03-26 |
| K241725 | Better Diagnostics Caries Assist (BDCA) Version 1.0 | Better Diagnostics AI Corp. | 2025-03-11 |
| K241620 | ChestView US | Gleamer Sas | 2025-02-27 |
| K242522 | Second Opinion CC | Pearl, Inc. | 2025-01-16 |
| K240003 | Velmeni for Dentists (V4D) | Velmeni, Inc. | 2024-08-30 |
| K233738 | Overjet Caries Assist-Pediatric | Overjet, Inc. | 2024-03-04 |
| K231805 | qXR-LN | Qure.Ai Technologies | 2023-12-22 |
| K232384 | Videa Dental Assist | Videahealth, Inc. | 2023-12-15 |
| K230144 | Denti.AI Detect | Denti.Ai Technology, Inc. | 2023-10-06 |
| K231001 | DeepTek CXR Analyzer v1.0 | Deeptek Medical Imaging Pvt, Ltd. | 2023-10-05 |
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| K223811 | Lung-CAD | Imagen Technologies, Inc. | 2023-09-13 |
| K223133 | VisiRad XR | Imidex, Inc. | 2023-08-03 |
| K221921 | DTX Studio Clinic 3.0 | Nobel Biocare AB | 2023-03-28 |
| K222746 | Overjet Caries Assist | Overjet, Inc. | 2023-03-27 |
Related GUDID Devices
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| 07332747221855 | DTX Studio™ Assist | Nobel Biocare AB | 2025-12-01 |
| 07332747221862 | DTX Studio™ Assist | Nobel Biocare AB | 2025-12-01 |
| 00198715016079 | Second Opinion | Pearl Inc. | 2025-07-31 |
| M722X25122C250640 | ClearRead Xray Detect | Riverain Technologies, Inc. | 2025-06-17 |
| M722XC25114C250640 | ClearRead Xray Detect | Riverain Technologies, Inc. | 2025-06-17 |
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| 08908023670038 | DeepTek CXR Analyzer | DEEPTEK MEDICAL IMAGING PRIVATE LIMITED | 2025-04-24 |
| 03770020839092 | ChestView US | GLEAMER | 2025-04-02 |
| M722X25064C250640 | ClearRead Xray Detect | Riverain Technologies, Inc. | 2025-03-27 |
| M722XC25064C250640 | ClearRead Xray Detect | Riverain Technologies, Inc. | 2025-03-27 |
| M722XD25064C250640 | ClearRead Xray Detect | Riverain Technologies, Inc. | 2025-03-27 |
| 00860003567920 | Second Opinion | Pearl Inc. | 2025-01-10 |
| 00860010893203 | Velmeni for Dentists | Velmeni Inc. | 2024-12-11 |
| 00860005586318 | Overjet Caries Assist | Overjet, Inc. | 2024-11-12 |
| 00860005586325 | Overjet Calculus Assist | Overjet, Inc. | 2024-11-12 |
| 00860005586332 | Overjet Periapical Radiolucency Assist | Overjet, Inc. | 2024-11-12 |
| 00860005586363 | Overjet Caries Assist-Pediatric | Overjet, Inc. | 2024-11-12 |
| B630QVCS346 | QVCAD System | QVIEW MEDICAL | 2024-06-26 |
| B630QVCSIK1202346 | QVCAD System Installation Kit | QVIEW MEDICAL | 2024-06-26 |
| 00850057636024 | qXR-LN | QURE.AI TECHNOLOGIES PRIVATE LIMITED | 2024-06-24 |
| 07332747215212 | DTX Studio™ Clinic | Nobel Biocare AB | 2024-04-17 |
| M722XD24079C212210 | ClearRead Xray | Detect | Riverain Technologies, Inc. | 2024-04-15 |
| 00860009836822 | Videa Dental Assist | Videahealth, Inc. | 2024-01-15 |
| 07332747207422 | DTX Studio™ AI SDK | Nobel Biocare AB | 2023-09-28 |
| 00852491008030 | Aorta-CAD | Imagen Technologies, Inc. | 2023-04-06 |
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| B630QVCS344 | QVCAD System | QVIEW MEDICAL | 2022-10-06 |
| M994MVU10500 | M-Vu Algorithm Engine | VUCOMP, INC. | 2015-02-25 |