← Product Code [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ) · K042334 # ALLURA 3D-CA, RELEASE 1 (K042334) _Philips Medical Systems North America Co. · LLZ · Sep 27, 2004 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K042334 ## Device Facts - **Applicant:** Philips Medical Systems North America Co. - **Product Code:** [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ.md) - **Decision Date:** Sep 27, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** 3rd-Party Reviewed ## Intended Use The Allura 3D-CA release 1 device is intended to assist physicians when analyzing 2-Dimensional X-ray images by creating 3-Dimensional views from a pair of 2-Dimensional images created during rotational angiographic runs. ## Device Story Allura 3D-CA release 1 is an image processing workstation integrated with a Philips Cardio-Vascular X-ray system via DICOM. Used in angiographic suite control rooms by physicians. Input: 2D X-ray projections from rotational angiographic scans (100-120 degree range). Operation: Uses cardiac modeling techniques to compensate for heart motion, constructing 3D surface models of coronary artery segments from two 2D projections. Output: 3D visualization of coronary arteries. Benefit: Assists physicians in analyzing complex coronary anatomy, potentially improving clinical decision-making during interventional procedures. ## Clinical Evidence No clinical data provided; substantial equivalence is based on technological characteristics and intended use. ## Technological Characteristics Image processing workstation; DICOM connectivity; cardiac modeling software for 3D surface reconstruction from 2D X-ray projections; complies with ACR/NEMA DICOM standards and UL safety standards. ## Regulatory 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). ## Predicate Devices - Integris 3D-RA release 4.2 ([K040254](/device/K040254.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # SEP 2 7 2004 ### 510(k) SUMMARY The following information is being submitted in accordance with the requirements of 21 CFR 807.92 | Company Name:
Address: | Philips Medical Systems North America Company
22100 Bothell Everett Highway
P.O.Box 3003
Bothell, WA 98041-3003, USA | |-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------| | Registration No .: | 1217116 | | Contact Person:
Telephone No.: | Lynn Harmer
(425) 487-7312 | | Date prepared: | 11 August 2004 | | Device (Trade) Name: | Allura 3D-CA, release 1 | | Regulation Name: | Picture archiving and communications system | | Regulation Number: | 21 CFR 892.2050 | | Regulatory Class: | II | | Product Code: | 90 LLZ | #### Predicate Device: The Allura 3D-CA release 1 device is substantially equivalent to the Integris 3D-RA release 4.2. (FDA ref. K040254) #### Device Description: The Allura 3D-CA release 1 device contains an image processing computer loaded with 3D-CA application software. It is linked through a DICOM port to a Philips Cardio-Vascular X-ray system and is intended to be placed in the control room of the Angiographic suite. 3D Coronary Angiography refers to 3D scanning of the coronary arteries, employing a C-arm based X-ray system. 2D projections are generated during a rotational scan, in which the patient's heart is scanned over an angular range of ca. 100-120 degrees. The complexity of making a 3D image of the coronary arteries is mainly caused by motion of the heart. 3D-CA uses a cardiac modeling technique to obtain a still 3D model of the heart. Cardiac modeling allows the construction of a 3D surface model of a coronary segment, or multiple segments, from two 2D projection images. #### Indications for Use: The Allura 3D-CA release 1 device is intended to assist physicians when analyzing 2-Dimensional X-ray images by creating 3-Dimensional views from a pair of 2-Dimensional images created during rotational angiographic runs. {1}------------------------------------------------ #### General Safety and Effectiveness: General Salety and Enconvolv with the applicable requirements of the federal The Gevice and tis laboling will Semply all Regulations, Title 21, subchapter J -- Radiological periormance standards (Ood of Packarlogally, the Allura 3D-CA release 1 complies with the ACR/NEMA DICOM digital imaging communication standard. The device will comply with applicable requirements of the Underwriters Laboratories Standard for The device will be million with applicable in a reports have been or will be supplied to the Salely - OL oversight agency to establish compliance with the applicable requirements. #### Conclusion: Conclusion. The Allura 3D-CA release 1 does not introduce new indications for use, nor does the use of the The Allura JD-OA release i Good nechikit addical Systems considers the Philips Allura 3D-CA release 1 substantially equivalent with the predicate device. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an emblem of an eagle with its wings spread. The eagle is facing to the left and has three lines extending from its head. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # Philips Medical Systems North America Company % Mr. Marc Mouser ` Senior Project Engineer/Program Reviewer Underwriters Laboratories, Inc. 2600 N.W. Lake Road CAMAS WA 98607-8542 #### Re: K042334 SEP 2 7 2004 Trade/Device Name: Allura 3D-CA Release 1 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: 90 LLZ and IZI Dated: September 16, 2004 Received: September 17, 2004 · Dear Mr. Mouser: 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 either class II (Special Controls) or class III (PMA), it may be subject to such 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. {3}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ough marked of substantial equivalence of your device to a legally prematication. The PDF mining 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 If you desire specific acrise to your of the following numbers, based on the regulation number at the top of the 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 Additionally, for questions on the please note the regulation entitled, "Misbranding Other of Othphanes as ( . ) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . by received to promaritor to promation the Act may be obtained from the Division of Small miorination on your responsibility of the Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Nancy C. Brygdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Page 1 of 1 510(k) Number (if known) : Device Name : Allura 3D-CA release 1 Indications For Use : The Allura 3D-CA release 1 is intended to assist physicians when analyzing 2-The Allura SD-OA Cloud 110 mensional views from a pair of 2-Dimensional A ray mages created during rotational angiographic runs. K642334 Prescription Use: X (Per 21 CFR 801.109) OR Over-The-Counter Use . . . . . (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David R. Syprom (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number K042334 (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K042334](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K042334) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com