HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System
K252018Samsung Medison Co., Ltd. · cleared 2026-01-05 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System are a general purpose, mobile, software controlled, diagnostic ultrasound system.”
source quote (p.13)
“A deep learning-based view classification and structure detection algorithm was validated using 43,737 fetal ultrasound images collected at hospitals.”
Validation studies (7)
Standalone
n=124 images
endpoints: Kidney Length Measurement Success Rate; Spleen Length Measurement Success Rate; Bland-Altman analysis (Bias, Limits of Agreement)
standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-4-2, ISO10993-1, ISO14971, NEMA UD 2-2004
Standalone
n=63 images
endpoints: Bladder Width Measurement Success Rate; Bland Altman analysis (Bias, Limits of Agreement)
standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-4-2, ISO10993-1, ISO14971, NEMA UD 2-2004
Standalone
n=43,737 images
endpoints: View quality classification and structure detection test; Sensitivity; Specificity; Positive Predictive Value (PPV); Negative Predictive Value (NPV)
standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-4-2, ISO10993-1, ISO14971, NEMA UD 2-2004
Standalone
n=120 cases
endpoints: Volume alignment acceptance rate; Levator hiatus (LH) measurement Intraclass Correlation Coefficient (ICC); Bland-Altman plot analysis
standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-4-2, ISO10993-1, ISO14971, NEMA UD 2-2004
Standalone
n=200 cases
endpoints: EzVolume Measurement test error rate; Bland-Altman analysis (Bias, Limits of Agreement)
standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-4-2, ISO10993-1, ISO14971, NEMA UD 2-2004
Standalone
n=120 images
endpoints: Segmentation test (average dice-score); Feature points extraction test (average error range); Size measurement test (average error range, Bland-Altman analysis)
standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-4-2, ISO10993-1, ISO14971, NEMA UD 2-2004
Standalone
n=46 patients
endpoints: Localization accuracy success rate; Processing speed (FPS)
standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-4-2, ISO10993-1, ISO14971, NEMA UD 2-2004
Reported performance (9 observations)
source quote (p.14)
“The Sensitivity ranged from 0.85 to 1.00, and the Specificity ranged from 0.85 to 1.00.”
source quote (p.14)
“The Sensitivity ranged from 0.85 to 1.00, and the Specificity ranged from 0.85 to 1.00.”
source quote (p.14)
“The Sensitivity ranged from 0.81 to 1.00, and the Specificity ranged from 0.99 to 1.00.”
source quote (p.14)
“The Sensitivity ranged from 0.81 to 1.00, and the Specificity ranged from 0.99 to 1.00.”
source quote (p.14)
“The Sensitivity ranged from 0.86 to 1.00, and the Specificity ranged from 0.85 to 1.00.”
source quote (p.14)
“The Sensitivity ranged from 0.86 to 1.00, and the Specificity ranged from 0.85 to 1.00.”
source quote (p.14)
“The Sensitivity ranged from 0.82 to 1.00, and the Specificity ranged from 1.00 to 1.00.”
source quote (p.14)
“The Sensitivity ranged from 0.82 to 1.00, and the Specificity ranged from 1.00 to 1.00.”
source quote (p.19)
“The feature demonstrated a localization accuracy success rate of 92.19% (95% CI: [90.03%, 94.34%]) and a processing speed of approximately 3.98 FPS.”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- recall_reason_pattern
Software/algorithm-related recall in product code IYN (Philips Ultrasound, LLC, initiated 2025-10-31): "Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97843
- recall_reason_pattern
Software/algorithm-related recall in product code IYN (GE Medical Systems, LLC, initiated 2025-09-18): "The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinica" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97726
- recall_reason_pattern
Software/algorithm-related recall in product code IYN (GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No., initiated 2025-05-16): "GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previou" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:96992
- recall_reason_pattern
Software/algorithm-related recall in product code IYN (Siemens Medical Solutions USA, Inc., initiated 2024-08-15): "If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems wi" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:95254
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).