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Final Camp quiz
Final Camp quiz
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1
Primary Regulation for SaMD in Europe
GDPR
MDR
HIPAA
ISO 14001
2
SaMD development uses which ISO standard for risk management?
ISO 14001
ISO 14971
ISO 27001
ISO 62304
3
What is the purpose of DICOM in medical imaging?
Creating AI predictions for medical imaging scans
Ensuring standardized data formats for medical images
Linking medical images with patient billing records
Compressing hospital network systems
4
Which of the following is NOT a commonly used healthcare app feature?
Symptoms checker
Cat GIF generator
Appointment scheduling
Medication reminders
5
What is the key characteristic of Software as a Medical Device (SaMD)?
It only works with hospital-grade devices
It performs medical tasks independently of hardware
It requires doctor approval to work
It can’t be used for diagnostics
6
What is HL7 designed for?
Predictive analytics in healthcare
Interoperable communication between healthcare systems
Medical data encryption
Building hospital equipment
7
What is the main purpose of PACS in hospitals?
Operating medical devices remotely
Replacing radiologists for imaging tasks
Diagnosing patient conditions
Storing and distributing medical images
8
How does the FDA classify SaMD?
By the AI depth used in its predictions
Based on its programming language
Based on the device’s risk to patients
By the number of users connected to the software
9
Which challenge is most common when integrating AI into healthcare systems?
Robots taking over hospital cafeterias
Doctors refusing to use computers
Patients demanding holographic doctors
Lack of access to quality data
10
Which regulatory body oversees medical devices in the United States?
PMDA
FDA
EMA
Health Canada
11
What does CE marking indicate on a medical device in Europe?
The device is only suitable for hospitals
he device has been certified by the WHO
The device is free for public use
The device meets EU safety and performance requirements
12
Which major tech company developed a wearable device with health-monitoring features (heart rate/ blood oxygen levels)?
Amazon
Snapchat
Microsoft
Apple
13
Which international standard defines the software life cycle processes for SaMD?
IEC 62304
FDA 21 CFR Part 820
ISO 9001
ISO 13485
14
What AI function detects tumors in MRI scans?
Object resizing
Image segmentation
Text annotation
Group clustering
15
Who’s the coolest, sharpest, and most curious team, always striving for new knowledge and growth?
Also us
Definitely us
All of the above
Us
16
Which scenario involves interoperability using HL7 standards?
Medical devices recording patient vitals
Hospital accounting software calculating payroll
A lab system sending test results to an EHR
Doctors sharing diagnoses over phone calls
17
What ensures implementation of a quality system during medical device development?
DICOM Imaging Standards
ISO 14001
ISO 13485
FHIR data exchange
18
Which device would NOT qualify for the De Novo pathway?
A new fitness and calorie tracker
Wearable blood glucose predictor
Novel imaging analysis systems
An AI-based tumor detection tool
19
Which of the following technologies is commonly employed in smart insulin pumps?
Internet of Things (IoT)
Quantum Computing
Virtual Reality
Augmented Reality (AR)
20
Which of the following is NOT a common imaging technique in medical diagnostics?
X-Ray
MRI (Magnetic Resonance Imaging)
CT (Computed Tomography)
JPG (Just Pictures, Generally)
21
What’s the difference between DICOM and PACS?
DICOM standardizes image formats; PACS stores and shares medical images
PACS runs scanner equipment; DICOM replaces radiologists
DICOM compresses files; PACS encrypts images
DICOM diagnoses abnormalities; PACS sorts data
22
What is a key requirement for using the 510(k) pathway?
It must show substantial equivalence to a predicate
The device must have no similar market devices
The device must provide new diagnostics
It must only target diagnostic imaging
23
What makes DICOM critical for interoperability in medical imaging technology?
It eliminates image distortion during scans
It encrypts patient data
It tracks medical imaging device usage
It standardizes imaging files for machines and software to communicate
24
Which of the following is an example of SaMD?
A smartphone app that detects melanoma risk from skin photos
A pacemaker firmware update tool
A CT scan operator’s control software
A blood glucose test strip monitor
25
Which AI application is commonly used for analyzing medical images like X-rays and MRIs?
Siri
DeepMind
Alexa
Photoshop
26
Which of these is part of DICOM metadata?
AI-based predictions
Device power levels
Radiologist notes
Patient name and imaging settings
