BEUDAMED
    Product Code: PGY FDA class 2 21 CFR 892.2050

    Display, Diagnostic Radiology

    Radiology

    The Diagnostic Radiology Display is a medical-grade monitor intended for use by trained medical practitioners to display radiological images for review, analysis, and diagnosis. It is an FDA Class 2 device regulated under 21 CFR 892.2050, requiring 510(k) premarket notification, within the Radiology (RA) medical specialty. The product code is PGY, and it is eligible for third-party review. This device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    135
    FEI Numbers
    21
    Registration Numbers
    21
    Unique Applicants
    19
    Years Active
    12

    Basic Information

    Product Code
    PGY
    Device Class
    FDA class 2
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Review Panel
    RA
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 135 510(k) clearances via K numbers.

    K Number Device Name
    K261213 Medical Monitor (40HT513D)
    K252780 LCD Monitor (CL1902A, CL2103F)
    K253242 LCD Monitor (C1216W, C822W, C821W)
    K252030 RadiForce GX570; RadiForce GX570-AR
    K243221 RadiForce RX570; RadiForce RX570-AR
    K243031 LCD Monitors C310S, G310S, C316S, G316S, C616W
    K242008 Coronis OneLook
    K241105 3MP Color LCD Monitor (CL-S301)
    K241441 RadiForce RX670; RadiForce RX670-AR
    K241499 21.3” 5MP Color LCD Display UMD5-21B01
    K233336 21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01)
    K240310 LCD Monitors C310S, G310S, C316S, G316S, C616W
    K240130 Medical Monitor (21HQ613D)
    K233897 5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S)
    K233465 RadiForce MX317W
    K233693 Nio Color 8MP (MDNC-8132)
    K232985 24HR513C
    K231026 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models)
    K232127 21HQ513D, 32HL512D, 31HN713D, 32HQ713D
    K230728 JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor
    K231170 C350/C350G LCD Monitor; M550/M550G LCD Monitor
    K230723 C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor
    K230684 RadiForce MX217
    K222719 CX50N
    K222716 MX50N
    K230643 CP620G LCD monitor, CP620 LCD monitor
    K230845 32HL512D, 31HN713D, 32HQ713D
    K223768 RadiForce RX270
    K230520 Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)
    K223423 32HQ713D
    K223789 21HQ513D
    K222864 8MP Color LCD Monitor CL-R813
    K222208 Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D
    K222132 Hisense LCD monitor HMD2G21S, HMD3G21S
    K222722 CW60N
    K222717 CL24N
    K222121 C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD monitor
    K221567 LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)
    K221061 21HQ613D
    K221136 RadiForce MX243W
    K212231 C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor
    K212985 6MP Color LCD Monitor CL-S600
    K212295 21HQ513D
    K211491 RadiForce RX370
    K203733 12MP Color Digital Mammography LCD Monitor CL-S1200
    K210345 2MP Monochrome LCD Monitor MS-S200
    K210493 CX30N (CX30PQX)
    K210491 CW120N
    K203106 Nio Fusion 12MP (MDNC-12130)
    K202374 4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+
    K201777 31HN713D
    K201211 3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+
    K200742 JUSHA-CP610 LCD Monitor
    K201599 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+
    K200889 iMac 27 & PL 4.0
    K200864 5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+
    K200485 RadiForce RX1270, RadiForce RX1270-AR
    K191705 OptikView GUP2103CMI
    K192925 32HL512D
    K200161 3MP Monochrome Digital Mammography LCD Monitor MS-S300
    K191864 21HK512D
    K191845 Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)
    K191137 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500
    K190848 JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor
    K183496 JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor
    K183494 R190/R191 LCD Monitor
    K183492 JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD Monitor
    K190153 RadiForce MX216
    K183498 JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD Monitor
    K183499 JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor
    K183497 JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 LCD Monitor
    K182291 6MP Color LCD Monitor (C61W+)
    K182591 RadiForce RX360, RX360-AR
    K182539 2MP Color LCD Monitor CL-R211
    K181609 RadiForce GX560, GX560-AR
    K180961 RadiForce MX194
    K173434 2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300
    K172738 RadiForce RX560, RX560-AR
    K172815 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)
    K171812 Nio Color 2MP (MDNC-2123)
    K171229 DELL UP3017 with QUBYX PerfectLum bundle
    K170944 LCD Monitor (MD310C, MD310G, MD210G)
    K170949 RadiForce MX315W
    K170837 Nio Color 3MP (MDNC-3421)
    K170781 MX50N(MX50YQS)
    K170783 CX50N(CX50YQS)
    K170476 Nio Color 5.8MP (MDNC-6121)
    K163335 6MP Color LCD Monitor, RadiForce RX660, RX660-AR
    K162527 8MP Color LCD Monitor (C81W+)
    K162497 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR
    K161895 2MP Color LCD Monitor CCL214 (CL21214)
    K162196 Dell UP3216Q with QUBYX PerfectLum bundle
    K161229 Mammo Tomosynthesis (MDMG-5221)
    K161057 Diagnostic Imaging Color LCD Monitor
    K160354 MX50T(MX50TQS)
    K160353 MX50N(MX50YQS)
    K160348 CX30N (CX30PQX)
    K160346 MX30N(MX30TQS)
    K160355 CX20N(CX20PUX)
    K160351 CX50N, CX50YQS
    K160347 Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21
    K160328 DIVA ZSP2105CMI with QUBYX PerfectLum bundle
    K160326 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)
    K160247 2MP Color LCD Monitor, RadiForce RX250 and RX250-AR
    K153354 3MP Color LCD Monitor, RadiForce RX350
    K152713 8MP Color LCD Monitor, RadiForce RX850, RX850-AR
    K152847 DIVA ZSP5812CMI with QUBYX PerfectLum bundle
    K152030 Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21)
    K151972 JUSHA-C43 LCD Monitor
    K151861 JUSHA-C23C LCD Monitor
    K151883 5MP Monochrome LCD Monitor, RadiForce GX540
    K151505 Coronis Uniti
    K151238 JUSHA-M23C LCD Monitor
    K151134 21.3 inch (54cm) Color LCD Monitor CCL210 (CL21210)
    K151007 21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550)
    K150842 JUSHA-M53 Medical Display
    K150746 JUSHA-M52C Medical Display
    K150821 MDNG-3220 (Nio 3MP LED)
    K150106 2MP Color LCD Monitor, RadiForce RS240
    K150145 MD322C8 31.5 Diagnostic Imaging LCD Monitor
    K143718 Mammography Color Display DP-M3010
    K142951 MD210C3 21.3 Diagnostic Imaging LCD Monitor
    K143261 2.3MP Color LCD Monitor, RadiForce MX242W
    K143098 3MP Color LCD monitor, RadiForce RS340
    K143157 Coronis Fusion 4MP LED
    K143076 20.1 inch (51cm) Monochrome LCD Monitor ME205 (ML20205)
    K142540 24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244)
    K142536 21.5 inch (54.5 cm) Color LCD Monitor CCL220 (CL22220)
    K141891 MEDICAL LCD MONITOR
    K141690 JUSHA-M33C LCD MONITOR
    K141684 JUSHA-C33C LCD MONITOR
    K141679 JUSHA-C61 LCD MONITOR
    K131601 DELL U3014 WITH QUBYX PERFECTLUM BUNDLE
    K141428 MDMC-12133
    K140702 8MP COLOR LCD MONITOR, RADIFORCE RX850

    FEI Numbers

    This FDA classification entry is associated with 21 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 21 registration numbers. Click on an entry to view related FDA registrations.