K102123 · Viztek, Inc. · KPR · Jan 24, 2011 · Radiology
Device Facts
Record ID
K102123
Device Name
VIZION DR
Applicant
Viztek, Inc.
Product Code
KPR · Radiology
Decision Date
Jan 24, 2011
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.1680
Device Class
Class 2
Attributes
Pediatric
Indications for Use
ViZion DR is intended for digital image capture use in general radiographic examinations for adult and pediatric, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis and extremities.
Device Story
ViZion DR is a digital radiography system integrating a Samsung flat-panel X-ray detector (FPD) with Viztek Opal-RAD PACS software. The system captures X-ray signals via the FPD, which are processed by the interface software to produce digital radiographic images. Used in clinical settings as a replacement for conventional screen-film systems, it enables filmless imaging, improving cost-effectiveness and workflow. Healthcare providers view images via the PACS interface to support diagnostic decision-making. The device benefits patients by providing digital image capture for general radiographic examinations.
Clinical Evidence
Bench testing and laboratory analysis were performed. Clinical images were collected and compared to predicate devices, demonstrating equal or better image quality.
Technological Characteristics
System consists of a Samsung flat-panel X-ray detector (FPD) and Viztek Opal-RAD PACS software. Operates as a stationary digital X-ray system. Connectivity provided via PACS interface. Software utilizes object-oriented architecture for image acquisition and viewing.
Indications for Use
Indicated for digital radiographic image capture in adult and pediatric patients for skull, chest, shoulders, spine, abdomen, pelvis, and extremities. Contraindicated for fluoroscopy, angiography, and mammography.
Regulatory Classification
Identification
A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Special Controls
*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
{0}------------------------------------------------
## 510(k) Number K102123 Viztek, Inc. 6491 Powers Avenue Jacksonville. FL 32217 Phone: 800.366.5343 Fax: 904.448.9936 Date Prepared: July 21, 2010 Contact: Bruce Ashby, Sales and Marketing Manager 1. Identification of the Device: Proprietary-Trade Name: ViZion DR Classification Name: Solid State X-Ray Imager (Flat Panel/Digital Imager) 90 MQB. Common/Usual Name: Digital X-Ray Receptor Panel
510(k) Summarv
2. Equivalent legally marketed device: Viztek DR, K082604 and Viztek Opal-RAD™ K063337. This new device employs the identical digital panel described in K090742, the Samsung Digital Flat Panel
3. Indications for Use (intended use) ViZion DR is intended for digital image capture use in general radiographic examinations for Adult and Pediatric wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
4. Description of the Device: The ViZion DR system represents the straightforward intearation of two cleared devices. ViZion DR is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) K090742 (Samsung Flat-Panel X-Ray Detector), Samsung Mobile Display Co., Ltd. (this is the 510(k) for the flat panel detector) and Viztek's proprietary
OPAL-RAD PACS image viewing and acquire interface software technology, (K063337) which incorporates state of the art object-oriented software and connectivity. ViZion is designed to perform digital radiographic examinations in replacement for conventional film. This integrated platform provides the benefits of PACS with the with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operation of the Viztek PACS and Samsung FPD were not changed.
5. Safety and Effectiveness, comparison to predicate device. The results of bench and test laboratory indicates that the new device is as safe and effective as the predicate devices. Clinical images collected demonstrate equal or better image quality as compared to our predicates
> age 16-of 1455 1 of 1
JAN 2 4 2511
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's name in bold, uppercase letters. To the left of the text is a symbol that is part of the department's official branding.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Viztek, LLC % Daniel Kamm, P.E. Principal Consultant Kamm & Associates 8870 Ravello Ct NAPLES FL 34114
AUG 23 2013
Re: K102123
Trade/Device Name: ViZion DR, Digital Flat Panel X-Ray Detector System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MOB Dated: October 8, 2010 Received: October 14, 2010
Dear Mr. Kamm:
This letter corrects our substantially equivalent letter of January 24, 2011,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
{2}------------------------------------------------
medical device-related adverse events) (21 CFR 803); and good manufacturing practice mental device-leated adverse overity systems (QS) regulation (21 CFR Part 820). This letter requirements as be form in are quarte as described in your Section 510(k) premarket wnifanow you to oogin finding of substantial equivalence of your device to a legally marketed nonication. The FDF imany of Scation for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 11 you desire specific davice of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 9 150. Thise not 1000 1200 1000 1000 1000 100 100 100 100 100 100 100 100 100 100 100 under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Tou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
## Indications for Use
510(k) Number (if known): K10 ZI 23
Device Name: ViZion DR, Digital Flat Panel X-Ray Detector System
Indications For Use:
ViZion DR is intended for digital image capture use in general radiographic examinations for adult and pediattic, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis and extremities.
Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR, Office of In Vitro Diagnostic Devices (OVID)
Andel D'Hun
n of Radiological Office of In
510K K102123
Page I of I
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
