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135
25. Food and Drug Administration. Premarket Approval
(PMA). M1000 ImageChecker. P970058. Notice date
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accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.
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reviews/DEN170022.pdf
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https://www.accessdata.fda.gov/cdrh_docs/reviews/
DEN180001.pdf
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reviews/DEN180005.pdf
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cdrh_docs/reviews/DEN190040.pdf
32. Food and Drug Administration. Radiological devices
reclassification of medical image analyzers, Final Rule,
85 Fed. Reg. 3545. Federal Register website. Effective
21 February 2020. Accessed 14 June 2023. https://www.
govinfo.gov/content/pkg/FR-2020-01-22/pdf/2020-
00494.pdf
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tion document. DEN220063. Caption Interpretation
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June 2023. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfpmn/denovo.cfm?id=DEN220063
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digital-health-center-excellence/digital-health-poli-
cy-navigator
35. Tabatabaei MS, et al. An evaluation protocol for picture
archiving and communication system: a systematic
review. Acta Inform Med. 2017 25(4):250-253.
36. Food and Drug Administration. Medical devices
medical device classification regulations to conform
to medical software provisions in the 21st Century
Cures Act, Final Rule, 86 RIN: 0910-AH67.
Federal Register website. Effective 19 April 2021.
Accessed 13 June 2023. https://www.federalreg-
ister.gov/documents/2021/04/19/2021-07860/
medical-devices-medical-device-classification-regula-
tions-to-conform-to-medical-software-provisions
37. Bevins NB, et al. Practical application of AAPM Report
270 in display quality assurance: a report of Task Group
270. Verified 14 June 2023.
38. Food and Drug Administration. 510(k) summary of
safety and effectiveness. K213713. AI-Rad Companion
(Pulmonary) from Siemens Healthcare. Notification
11 August 2019. Accessed 15 June 2023. https://www.
accessdata.fda.gov/cdrh_docs/pdf21/K213713.pdf
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https://www.accessdata.fda.gov/cdrh_docs/pdf4/
K041555.pdf
41. Hadjiiski L, et al. AAPM Task Group Report 273:
AAPM task group report 273: recommendations on
best practices for AI and machine learning for com-
puter-aided diagnosis in medical imaging. Med Phys.
2023 50(2):e1-e24. Verified 13 June 2023.
42. Food and Drug Administration. 510(k) summary of
safety and effectiveness. K210666. ChestCAD from
Imagen Technologies, Inc. Notification 20 July 2021.
Accessed 15 June 2023. https://www.accessdata.fda.gov/
cdrh_docs/pdf21/K210666.pdf
43. Food and Drug Administration. 510(k) summary of
safety and effectiveness. K201560. Auto Lung Nodule
Detection from Samsung Electronics. Notification 31
August 2021. Accessed 15 June 2023. https://www.
accessdata.fda.gov/cdrh_docs/pdf20/K201560.pdf
44. Masud R, et al. Computer-aided detection for breast
cancer screening in clinical settings: scoping review.
JMIR Med Inform. 2019 7(3):e12660. Verified 3 July
2023.
45. Gallas BD, et al. Evaluating imaging and comput-
er-aided detection and diagnosis devices at the FDA.
Acad Radiol. 2012 19(4):463–477. Verified 13 June
2023.
46. Wu E, et al. How medical AI devices are evaluated:
limitations and recommendations from an analysis of
FDA approvals. Nat Med. 2021 27(4):576-584. Verified
15 June 2023.
47. Food and Drug Administration. 510(k) Summary of
Safety and Effectiveness. K221564. Brainomix 360
e-ASPECTS from Brainomix Limited. Notification 23
February 2021. Accessed 15 June 2023. https://www.
accessdata.fda.gov/cdrh_docs/pdf22/K221564.pdf