K023190 · Siemens Medical Solutions USA, Inc. · LLZ · Oct 24, 2002 · Radiology
Device Facts
Record ID
K023190
Device Name
E.CAM COMPUTER / E.SOFT WORKSTATION
Applicant
Siemens Medical Solutions USA, Inc.
Product Code
LLZ · Radiology
Decision Date
Oct 24, 2002
Decision
SESE
Submission Type
Special
Regulation
21 CFR 892.2050
Device Class
Class 2
Indications for Use
E.CAM Computer / e.soft Workstation is a Gamma Camera computer for nuclear medicine used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: - Planar Imaging - Whole body imaging - Tomographic imaging (SPECT) for non positron emitter - Positron imaging by coincidence - Positron imaging without coincidence up to 588 keV - Display and process nuclear medicine, PET and CT images
Device Story
E.CAM Computer/e.soft Workstation serves as the primary interface for Siemens E.CAM Gamma cameras and a processing/review platform for nuclear medicine and PET/CT images. Input data includes radionuclide distribution signals from Gamma cameras and external image data (NM, PET, CT) via DICOM/TCP/IP. The device performs image reconstruction, including Flash 3D OSEM modeling, attenuation correction using CT images, and PET quantification. Operated by clinicians in clinical settings, the system facilitates image review, processing, and storage. Output consists of processed diagnostic images and quantitative data, aiding healthcare providers in clinical decision-making regarding radionuclide distribution. HIPAA support is integrated for patient data privacy.
Clinical Evidence
No clinical data provided; substantial equivalence is based on design control activities, including Failure Modes and Effects Analysis (FEMA) and comparison of technological characteristics to predicate devices.
Technological Characteristics
Nuclear medicine imaging workstation; supports SPECT, PET, and CT image processing. Features Flash 3D OSEM reconstruction algorithm and CT-based attenuation correction. Connectivity via TCP/IP and DICOM for integration with PACS, HIS/RIS, and imaging modalities. Software-based platform for image acquisition, review, and quantification.
Indications for Use
Indicated for patients requiring nuclear medicine imaging, including planar, whole body, and SPECT imaging, as well as PET imaging (coincidence and non-coincidence). Used for the detection and imaging of radionuclide distribution in the body or organs.
Regulatory Classification
Identification
A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.
Special Controls
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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KO23190
## OCT 2 4 2002
# 510(k) SUMMARY
## [As required by 21 CFR 807.87(h)]
#### Identification of Submitter
Corresponding Official: Establishment:
Establishment Registration Number: Telephone Number: Fax Number: E-mail Address: Date of preparation:
Richard S. Demke Siemens Medical Solutions USA, Inc. Nuclear Medicine Group 2501 North Barrington Road Hoffman Estates, IL 60195 1423253 (Owner / Operator Number: 9010023) (847) 304-7516 (847) 304-6023 richard.demke@siemens.com
#### Identification of the Product
Device Proprietary Name: Classification Name:
Common Name: Product code: Class:
E.CAM Computer / e.soft Workstation Emission computed tomography system per 21 CFR 892.12000 2050 Nuclear Medicine Imaging system 90年 Class II
#### Models
- E.SOFT A Acquisition Review & Processing E.SOFT P E.SOFT V Review E.SOFT AP Acquisition, Review & Processing
#### Identification of Legally Marketed Equivalent Devices
| Device | Manufacturer | 510(k) Number |
|-------------------------------------------------------------------|-------------------------------------|---------------|
| E.CAM Computer | Siemens Medical Solutions USA, Inc. | K992731 |
| ICON Computer System | Siemens Medical Solutions USA, Inc. | K903315B |
| ADAC Pegasys | Phillips Medical Systems | K892358 |
| Hawkeye Option for Dual-<br>Headed Variable Angle<br>Gamma Camera | EL GEMS Ltd./ GE Medical | K991841 |
| ECAT PET SCANNER | CTI PET Systems, Inc. | K002715 |
000009
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### Page 2
### Device Description
E.CAM Computer / e.soft Workstation provides primary user interface for acquiring images from the Siemens E.CAM family of nuclear medicine Gamma cameras, as well as a collection of clinical applications for processing and review of images from any nuclear medicine and/or positron emission imaging systems. E.SOFT relies on standard networking and image transfer protocols (TCP/IP and DICOM) for connection to/from other devices, including NM, PET and CT imaging stations, image review/storage (PACS) stations, hardcopy devices, external archive devices and HIS/RIS (Hospital information/Radiological Information Systems).
### Description of Change or Modification
E.CAM Computer / e.soft Workstation is to be modified to provide attenuation correction with computed tomography images (CT), improved reconstruction with Flash 3D OSEM modeling, PET quantification activity and HIPAA (patient privacy) support.
### Intended Use of Device
E.CAM Computer / e.soft Workstation is a Gamma Camera computer for nuclear medicine used to detect or image the distribution of radionuclides in the body or organ, using the following techniques:
- . Planar Imaging
- Whole body imaging .
- Tomographic imaging (SPECT) for non positron emitter 、
- Positron imaging by coincidence .
- Positron imaging without coincidence up to 588 keV .
- Display and process nuclear medicine, PET and CT images .
### Device Comparison
Attenuation correction is performed by all SPECT vendors, including e.soft with an emission source. Attenuation correction with computed tomography images (CT) is currently performed by GE Medical Systems (K991841). Most SPECT devices support OSEM Reconstruction. E.soft will provide improved processing with Flash 3D OSEM Reconstruction. Pet quantification activity streamlines the use of PET data by combining new & existing pet related displays & processing the data in a single protocol (or activity). The concerns of patient data security, access & privacy are accomplished by supporting the HIPAA directives.
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Page 3
### Summary of Design Control Activities
The risk analysis method used to assess the impact of the modifications was based on a Failure Modes and Effects Analysis (FEMA). This analysis built upon the previous risk analysis and incorporated the software modifications indicated in this submission.
### Substantial Equivalence
The modified E.CAM Computer / e.soft Workstation has the following similarities to the product which previously received 510(k) clearance:
- 트 have the same indicated use,
- 내 use the same operating principle,
- . incorporate the same basic product design
In summary, the E.CAM Computer described in this submission is, in our opinion, substantially equivalent to the predicate devices.
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#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows a logo with a stylized bird figure. The bird is composed of three curved lines that suggest wings or feathers. The logo is encircled by text, which is partially obscured but appears to read 'Department of Human Resources'.
#### Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 4 2002
Re: K023190
Mr. Richard S. Demke Manager, Regulatory Affairs Siemens Medical Solutions USA, Inc. 2501 North Barrington Road HOFFMAN ESTATES IL 60195-5203
Trade/Device Name: E.CAM Computer/e.soft Workstation Emission Tomography System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: 90 LLZ Dated: September 26, 2002 Received: September 25, 2002
Dear Mr. Demke:
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 (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|------------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx . | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Snogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indication for Use Statement
510(k) Number
(if known)
K023190
Device Name:
E.CAM Computer / e.soft Workstation, Emission Tomography System
(Computer)
Indications For Use: E.CAM Computer / e.soft Workstation is a Gamma Camera computer for
nuclear medicine used to detect or image the distribution of
radionuclides in the body or organ, using the following techniques:
- Planar Imaging
- Whole body imaging
- Tomographic imaging (SPECT) for non positron emitter
- Positron imaging by coincidence
- Positron imaging without coincidence up to 588 keV
- Display and process nuclear medicine, PET and CT images
#### (PLEASE DO NOT WRITE BELOW THIS LINE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(Optional Format 1-2-96)
David G. Seymour
(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number __
000007
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.
