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Emory Cardiac Toolbox

Model 4.0.5121.18001 · SYNTERMED INCORPORATED · DI B133ECTB40

KPS — System, Tomography, Computed, Emission · Class II · 21 CFR 892.1200

UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

12342019-03: 0 reports for this device; peer average 2/device2019-04: 0 reports for this device; peer average 2/device2019-05: 0 reports for this device; peer average 4/device2019-08: 0 reports for this device; peer average 2/device2020-01: 0 reports for this device; peer average 1/device2020-03: 0 reports for this device; peer average 2/device2020-09: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 2/device2022-04: 0 reports for this device; peer average 3/device2022-05: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 2/device2023-06: 0 reports for this device; peer average 1/device2023-12: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 3/device2024-05: 0 reports for this device; peer average 3.33/device2024-06: 0 reports for this device; peer average 3/device2024-08: 0 reports for this device; peer average 1.5/device2025-02: 0 reports for this device; peer average 1/device2025-06: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 1/device2025-11: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 1/device0304050801030902040509061203040506080206101112
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0302
2019-0402
2019-0504
2019-0802
2020-0101
2020-0302
2020-0901
2021-0202
2022-0403
2022-0501
2022-0902
2023-0601
2023-1201
2024-0301
2024-0403
2024-0503.33
2024-0603
2024-0801.5
2025-0201
2025-0601
2025-1001
2025-1101
2025-1201
This device (reports/month)Average device in KPS (reports/device/month)

Regulatory clearances

  • K123646 SESE 2013-02-22 (k number procode)

Predicate lineage

K123646 — cites (transitively): K014033 (d1), K071503 (d1), K101279 (d1), K110071 (d1), K113754 (d1), K992450 (d1), K003437 (d2), K023190 (d2), K063762 (d2), K080575 (d2), K083327 (d2), K072242 (d2), K080770 (d2) — cited as predicate by K192630, K223422, K231731

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — SYNTERMED INCORPORATED

  • NAI 2022-08-11 Syntermed, Inc. · 0 citations
  • NAI 2022-08-11 Syntermed, Inc. · 0 citations
  • NAI 2018-05-23 Syntermed, Inc. · 0 citations
  • NAI 2018-05-23 Syntermed, Inc. · 0 citations
  • NAI 2012-11-30 Syntermed, Inc. · 4 citations
  • NAI 2012-11-30 Syntermed, Inc. · 4 citations
  • VAI 2010-03-22 Syntermed, Inc. · 1 citations
  • VAI 2010-03-22 Syntermed, Inc. · 1 citations