Chapter 8. Artificial Intelligence-based Software
136 Regulatory Affairs Professionals Society (RAPS)
48. Food and Drug Administration. 510(k) Summary of
Safety and Effectiveness. K214043. BriefCase from
Aidoc Medical, Ltd. Notification 14 March 2022.
Accessed 15 June 2023. https://www.accessdata.fda.gov/
cdrh_docs/pdf21/K214043.pdf
49. Food and Drug Administration. 510(k) Summary of
Safety and Effectiveness. K222268. Annalise Enterprise
CXR Triage Trauma from Annalise-AI Pty Ltd.
Notification 28 March 2023. Accessed 15 June 2023.
https://www.accessdata.fda.gov/cdrh_docs/pdf22/
K222268.pdf
50. Food and Drug Administration. 510(k) Summary
of Safety and Effectiveness. K203260. syngo. CT
Brain Hemorrhage from Siemens Medical Solutions.
Notification 28 January 2022. Accessed 15 June 2023.
https://www.accessdata.fda.gov/cdrh_docs/pdf20/
K203260.pdf
51. Food and Drug Administration. Technical performance
assessment of quantitative imaging in radiological
device premarket submissions [guidance]. Current as of
16 June 2022. Accessed 3 July 2023. https://www.fda.
gov/media/123271/download
52. Food and Drug Administration. FDA and industry
actions on premarket notification (510(k)) submissions:
effect on FDA review clock and goals [guidance].
Current as of 3 October 2022. Accessed 3 July 2023.
https://www.fda.gov/media/73507/download
53. Benjamens S, et al. The state of artificial intelli-
gence-based FDA-approved medical devices and
algorithms: an online database. NPJ Digit Med.
2020 118 (3):1-8. Verified 7 July 2023.
54. Lopez-Jimenez F, et al. Artificial intelligence (AI)
in cardiology: present and future. Mayo Clin Proc.
2020 95(5) 1015-1039. Verified 10 October 2023
55. Food and Drug Administration. 510(k) Summary of
Safety and Effectiveness. K213657. Deepvessel FFR
from KeyaMed NA Inc. Notification 1 April 2022.
Accessed 15 June 2023. https://www.accessdata.fda.gov/
cdrh_docs/pdf21/K213657.pdf
56. Food and Drug Administration. 510(k) Summary of
Safety and Effectiveness. K203329. HeartFlow Analysis
from HeartFlow Inc. Notification 8 January 2021.
Accessed 15 June 2023. https://www.accessdata.fda.gov/
cdrh_docs/pdf20/K203329.pdf
57. Food and Drug Administration. 510(k) Summary
of Safety and Effectiveness. K214066. FEops
HEARTguide from FEops nv. Notification 25 February
2022. Accessed 15 June 2023. https://www.accessdata.
fda.gov/cdrh_docs/pdf21/K214066.pdf
58. Food and Drug Administration. 510(k) Summary of
Safety and Effectiveness. K183202. Deep Learning
Image Reconstruction from GE Medical Systems.
Notification 12 April 2019. Accessed 15 June 2023.
https://www.accessdata.fda.gov/cdrh_docs/pdf18/
K183202.pdf
59. Food and Drug Administration. 510(k) Summary of
Safety and Effectiveness. K182901. Aquilion Precision
(TSX‐304A/1 and /2) V8.8 with AiCE from Canon
Medical Systems Corporation. Notification 5 July 2019.
Accessed 15 June 2023. https://www.accessdata.fda.gov/
cdrh_docs/pdf18/K182901.pdf
60. Food and Drug Administration. 510(k) Summary of
Safety and Effectiveness. K220939. MAGNETOM
Lumina and MAGNETOM Vida Fit from Siemens
Medical Solutions. Notification 29 April 2022.
Accessed 15 June 2023. https://www.accessdata.fda.gov/
cdrh_docs/pdf22/K220939.pdf
61. Li Y, et al. Utility of phantom-based testing for
evaluating the performance of AI in MRI image recon-
struction. Proc. SPIE, Medical Imaging 2023: Physics
Medical Imaging. 2023 12463:632-639. Verified 27
October 2023.
62. Food and Drug Administration. 510(k) Summary
of Safety and Effectiveness. K113483. Philips IRT
Software Application from Philips Medical Systems.
Notification 26 September 2012. Accessed 15 June
2023. https://www.accessdata.fda.gov/cdrh_docs/pdf11/
K113483.pdf
63. Food and Drug Administration. 510(k) Summary of
Safety and Effectiveness. K183046. Aquilion ONE
(TSX-305A/6) V8.9 with AiCE from Canon Medical
Systems. Notification 12 June 2019. Accessed 15 June
2023. https://www.accessdata.fda.gov/cdrh_docs/pdf18/
K183046.pdf
64. Honavar SG. Artificial intelligence in ophthalmol-
ogy -machines think! Indian J Ophthalmol. 2022
70(4) 1075-1079. Verified 8 July 2023.
65. Srivastava O, et al. Artificial intelligence and machine
learning in ophthalmology: A review. Indian J
Ophthalmol. 2023 71(1) 11-17. Verified 8 July 2023.
66. 21 CFR §886.1100. Retinal diagnostic software device.
Current as of 25 October 2023. Accessed 27 October
2023. https://www.ecfr.gov/current/title-21/chapter-I/
subchapter-H/part-886/subpart-B/section-886.1100
67. International Medical Device Regulators Forum.
Software as a medical device: possible framework for
risk categorization and corresponding considerations.
WG/N12FINAL:2014. Published 18 September
2014. Accessed 8 July 2023. https://www.imdrf.
org/sites/default/files/docs/imdrf/final/technical/
imdrf-tech-140918-samd-framework-risk-categoriza-
tion-141013.pdf
68. Food and Drug Administration. Good machine learn-
ing practice for medical device development: guiding
principles. Current as of 27 October 2021. Accessed
15 June 2023. https://www.fda.gov/media/153486/
download
69. Berkman S, et al. Deep Learning in medical imaging
and radiation therapy. Med. Phys. 2019 46(1) e1-e36.
Verified 8 July 2023.
70. Nelson BJ, et al. An FDA guide on indications for use
and device reporting of artificial intelligence enabled
devices: significance for pediatric use. J Am Coll Radiol.
2023 20(8):738-741. Verified 13 October 2023.
Previous Page Next Page