510(k) K801512
- Device
- DOPPLER ULTRASONIC STETHOSCOPE
- Applicant
- MOUNTAIN MEDICAL EQUIPMENT, INC.
- 510(k) number
- K801512
- Product code
- IYN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-08-20
- Date received
- 1980-06-30
- Regulation
- 892.1550
- Classification name
- System, Imaging, Pulsed Doppler, Ultrasonic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3033527241
- 9710602
- 3005810333
- 3003774756
- 3011162972
- 2029275
- 3004705634
- 3007194257
- 3002183074
- 3034232408
- 3014680735
- 3006441164
- 3004485675
- 3013844297
- 8041160
- 3015525240
- 3017955833
- 3006680097
- 3009499478
- 3042225166
- 3003600763
- 3017487805
- 1066270
- 8043933
- 3011688715
- 3011416394
- 3014574557
- 1937397
- 8010047
- 3011050570
- 3015997711
- 3010400367
- 3015499445
- 3004752776
- 3032008018
- 3006260740
- 3018094310
- 3009758186
- 3010102386
- 3011686611
- 3009196578
- 3006985147
- 3009247326
- 3008492462
- 3031823165
- 3019784575
- 3003412859
- 3006161756
- 2245304
- 3010220244
- 3003851073
- 3009286597
- 3003681187
- 2532090
- 3013041594
- 3010398867
- 3025786376
- 3003591740
- 3016854601
- 9680269
- 3026405201
- 2939830
- 3005403518
- 3000976525
- 3008487708
- 3005049530
- 9610482
- 3010703925
- 3014745562
- 3015276088
- 3029937167
- 3043534483
- 3035950510
- 2134213
- 3009293490
- 3014302721
- 3025429169
- 3033508292
- 3007994837
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IYN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253949 | SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6 | CHISON Medical Technologies Co., Ltd. | 2026-05-22 |
| K253720 | uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite | Wuhan United Imaging Healthcare Co.,Ltd | 2026-05-21 |
| K254028 | Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra 65, Autra 55, Autra 65i, Autra 90 Elite, Autra 85 Elite, Autra 80 Elite, Autra 75 Elite, Autra 85 CV, Autra 80W, Autra 65 Elite, Autra 55 Elite, Autra 55i, Autra 90 CV, Autra 85, Autra 80, Autra 80 CV, Autra 75 Pro, Autra 75W, Autra 70 Elite, Autra 70, Autra T) | Sonoscape Medical Corp. | 2026-05-15 |
| K253716 | uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus Super | Wuhan United Imaging Healthcare Co.,Ltd | 2026-05-15 |
| K260111 | Palmtop Ultrasound Diagnostic System (MT10P/MT10) | Mytech Intelligence (Shenzhen) Co., Ltd. | 2026-05-14 |
| K260846 | Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ultrasound System (MU9 Exp);Diagnostic Ultrasound System (MU9 Pro);Diagnostic Ultrasound System (MU9 Super);Diagnostic Ultrasound System (MU9P);Diagnostic Ultrasound System (MU9A);Diagnostic Ultrasound System (MU7);Diagnostic Ultrasound System (MU7S);Diagnostic Ultrasound System (MU7T);Diagnostic Ultrasound System (MU7 Exp);Diagnostic Ultrasound System (MU7 Pro);Diagnos | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-05-11 |
| K261132 | Healium Intelliscan LX192LC | Healium Intelliscan Corporation | 2026-05-05 |
| K252558 | Lumify Diagnostic Ultrasound System | Philips Ultrasound, LLC | 2026-05-05 |
| K260589 | ES-Series | E-Scopics | 2026-04-29 |
| K253288 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | Esaote, S.p.A. | 2026-04-06 |
| K252709 | Wireless Probe Type Ultrasound Scanner | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | 2026-04-02 |
| K253595 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | 2026-03-27 |
| K254099 | EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2026-03-27 |
| K252148 | Butterfly Gestational Age Tool | Butterfly Network, Inc. | 2026-03-27 |
| K260673 | LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026-03-24 |
Legacy Summary#
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FDA Review#
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