Who is the manufacturer of DIGITAL IMAGING SYSTEM?

Camtronics, Ltd. filed the 510(k) submission for DIGITAL IMAGING SYSTEM (K954159).

What is the FDA product code for DIGITAL IMAGING SYSTEM?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for DIGITAL IMAGING SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like DIGITAL IMAGING SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DIGITAL IMAGING SYSTEM

Q: What are the predicate devices for DIGITAL IMAGING SYSTEM?

Camtronics Video Plus (K941979); Siemens Medical Systems Fluorospot H version 2 (K914525).

K954159 · Camtronics, Ltd. · LLZ · Mar 19, 1996 · Radiology

Device Facts

Record ID	K954159
Device Name	DIGITAL IMAGING SYSTEM
Applicant	Camtronics, Ltd.
Product Code	LLZ · Radiology
Decision Date	Mar 19, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2

Intended Use

Image Acquisition Display Control/Image Processing Input/Output Control Patient Data Management

Device Story

Digital imaging system for cardiac catheterization or radiography/fluoroscopy suites; records and displays medical images. Inputs include fluoroscopic and radiographic signals; system performs image processing (window/level, edge enhancement, zoom, roam, roadmapping, peak opacification, remask, pixel shift, annotation, qualitative analysis). Outputs include processed images and patient data displayed for clinical review. Operated by physicians or technicians in clinical settings. Supports various acquisition modes including DSA, peripheral angiography, digital tomography, rotational angiography, and ECG-gated acquisition. Facilitates clinical decision-making by providing enhanced visualization and management of diagnostic images.

Clinical Evidence

No clinical data provided; performance data not required for determination of substantial equivalence for this class of device.

Technological Characteristics

Digital image recording and display system. Matrix size: 512² to 2068². Bit depth: 8, 10, or 12. Storage: 1 gigabyte minimum. Features include networking, cine, filmless cine, and synchronized biplane acquisition. Supports various acquisition modes including DSA, peripheral angiography, digital tomography, rotational angiography, and ECG-gated acquisition.

Indications for Use

Indicated for use in cardiac catheterization laboratories or radiography/fluoroscopy suites for the acquisition, display, processing, and management of medical images.

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).

Predicate Devices

Camtronics Video Plus (K941979)
Siemens Medical Systems Fluorospot H version 2 (K914525)

Related Devices

K955519 — ANALYTICAL REVIEW STATION · Camtronics, Ltd. · May 9, 1996
K030544 — RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM · Sigma Vision, Inc. · May 21, 2003
K024200 — INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION) · Ge Medical Systems, Inc. · Jan 16, 2003
K983088 — INSTACINE D-2000 · Fidelity Medical, Inc. · Sep 22, 1998
K041027 — DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR, MODEL DFP8000D · Toshibamedical Systems Corporation · May 14, 2004

Submission Summary (Full Text)

{0} Camtronics MEDICAL SYSTEMS K954159 # 510(k) Summary MAR 19 1996 Date prepared: August 28, 1995 Name of contact person: Robert Kriedermann Device trade name: Digital Imaging System Common name: Digital Imaging System Classification name: Medical Image Picture Archiving and Communications Device Predicate substantially equivalent devices: Camtronics Ltd. Video Plus (K941979), Siemens Medical Systems Fluorospot H version 2 (K914525) Device description: Digital image recording and display system to use in a cardiac catheterization laboratory or radiography/fluoroscopy suite. Intended use: - Image Acquisition - Display Control/Image Processing - Input/Output Control - Patient Data Management ## Predicate device specifications comparison: | Feature | Principal Device | Predicate Device | Predicate Device | | --- | --- | --- | --- | | Feature | Camtronics Digital Imaging System | Camtronics Video Plus (K941979) | Siemens Fluorospot H version 2 (K914525) | | Matrix size | 512² to 2068² | 512² to 1024² | 1024² | | Max. acquisition rate | 60 fps | 60 fps | 8 fps | | Bit depth | 8, 10, or 12 | 8 | 8 | | Image storage | 1 gigabyte minimum | 1 gigabyte minimum | 650 megabyte | | Networking | yes | yes | yes | | Supported procedures | | | | | Fluoro Acquisition | yes | yes | yes | | Fluoro Loop Record | yes | yes | yes | | Roadmapping Fluoro Acquisition | yes | yes | yes | | Spot Film Verification | yes | yes | yes | | Digital Spot Acquisition | yes | yes | yes | | Digital Subtraction Angiography Acquisition (DSA) | yes | yes | yes | | Peripheral Angiography Acquisition (PERI) | yes | no | yes | | Digital Tomography Acquisition (TOMO) | yes | no | yes | | Rotational Angiography Acquisition | yes | no | yes | | ECG Gated Acquisition | yes | no | no | | ECG Trace(s) Display | yes | no | no | | Cine | yes | yes | no | | Filmless Cine | yes | yes | no | | Electrophysiology (EP) | yes | no | no | | Synchronized Biplane Acquisition | yes | yes | no | Camtronics Ltd., A Subsidiary of ANALOGIC Corporation 900 Walnut Ridge Drive • P.O. Box 950 • Hartland, WI 53029 • 414-367-0700 • Fax: 414-367-0717 {1} 445-5 Page 2 Camtronics Digital Imaging System 510(k) Summary August 28, 1995 Predicate device specifications comparison (continued): | Feature | Principal Device Camtronics Digital Imaging System | Predicate Device Camtronics Video Plus (K941979) | Predicate Device Siemens Fluorospot H version 2 (K914525) | | --- | --- | --- | --- | | Window/level | yes | yes | yes | | Edge enhancement | yes | yes | yes | | Zoom | yes | yes | yes | | Roam | yes | yes | yes | | Roadmapping | yes | yes | yes | | Peak opacification | yes | yes | yes | | Remask | yes | yes | yes | | Pixel shift | yes | yes | yes | | Annotation | yes | yes | no | | Qualitative analysis | yes | yes | no | Performance data: Not required for determination of substantial equivalence for this class of device. Conclusions drawn from clinical and nonclinical test data: Not required for determination of substantial equivalence for this class of device.