(14 days)
Not Found
No
The summary describes standard image processing and analysis software for a gamma camera, with no mention of AI, ML, or related concepts. The device is explicitly stated as "not interpretative," relying on medical personnel for diagnosis.
No.
The device is used for imaging and diagnosis, not for treating diseases or conditions.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The CapIMAGE Gamma Camera System is intended for examination (and diagnosis) of disorders and diseases in the thyroid gland, the heart and other small organs." This indicates its role in identifying and characterizing medical conditions, which is the definition of a diagnostic device.
No
The device description explicitly states it is a "mobile Small Field of View (SFOV) gamma camera system utilizing a scintillation detector to detect gamma rays," indicating it includes hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, tissue) to provide information for diagnostic purposes. This examination happens outside of the living body (in vitro).
- CapIMAGE Function: The CapIMAGE Gamma Camera System works by detecting gamma rays emitted from radioisotopes within the human body. It produces images of the anatomical distribution of these radioisotopes. This is an in vivo process, meaning it happens within the living body.
The device is a medical imaging system used for in vivo diagnostic imaging, not for analyzing samples in vitro.
N/A
Intended Use / Indications for Use
The CapIMAGE Gamma Camera System is intended to produce planar images depicting the anatomical distributions of single photon emitting radioisotopes in the human body within the energy range of 59kev to 167kev. The system provides software applications for processing, analyzing, and displaying medical images for interpretation by medical personnel.
The CapIMAGE Gamma Camera System is intended for examination (and diagnosis) of disorders and diseases in the thyroid gland, the heart and other small organs. The device is not interpretative. Data from the device are interpreted by medical personnel who, based on these, make the clinical diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
IYX
Device Description
The CapIMAGE is a mobile Small Field of View (SFOV) gamma camera system utilizing a scintillation detector to detect gamma rays. The CapIMAGE is designed to be manually transported and deployed for scanning of patients in laying, sitting or standing positions. The system can operate powered from mains or from the internal battery source for at least 60 min.
Analog signals from the photo multiplier tubes are summed into position and energy signals and sent to the camera console digitization and correction. The corrected data are hereafter send to a laptop PC located on top of the camera console, acting as a combined control and user interface to the system. Detector positioning is done using the persistence display mode on the PC, showing radioactive emission from the patient. The vertical detector positioning is motorised, all other positioning is done manually, using controls on the detector, including acquisition start and stop. The PC user interface (UI) enables the user to enter image acquisition parameters and to start and stop image acquisition. Following acquisition, images can be reviewed on the PC, processed and/or transferred to a peripheral device using DICOM.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Gamma Camera
Anatomical Site
thyroid gland, the heart and other small organs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Performance Data: The CapIMAGE performance characteristics have been tested in accordance with applicable standards for medical device during which the CapIMAGE has shown full compliance.
Safety and effectiveness: Compliance to all relevant parts of the UL 60601-1, IEC601-1, IEC601-1-1 and IEC601-1-2 standards.
Performance specifications: Compliance to all relevant parts of the NEMA NU 1-2001 standard.
Based on these data it is concluded that the CapIMAGE provides effective results equivalent to those from the predicate device, the CardioMD.
Clinical Performance Data: None.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1100 Scintillation (gamma) camera.
(a)
Identification. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class I (general controls).
0
Image /page/0/Picture/0 description: The image contains three stylized letter D's in a row. Each D is outlined with a thicker line, and has a smaller, rounded rectangle inside, creating a hollow effect. The D's are evenly spaced and appear to be part of a logo or design element.
Diagnostic
Danish Diagnostic Development A/S
JUL 11 2008
Dr. Neergaards Vej 5F Scion DTD DK-2970 Hoersholm Denmark
June 10, 2008
CapIMAGE Gamma Camera System
510(k) Summary" as required by section 807.92(c).
K68/879 Assigned 510(K) number:
Submitter Information. 1.
| Submitted by: | 3D, Danish Diagnostic Development A/S
Dr. Neergaardsvej 5F
2970 Horsholm, Denmark
Tel: +45 45 768888
Fax: +45 45 164659 |
| --------------- | ------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Contact person:
Niels Sorensen QA manager. Tel: + 45 45 768888 Fax: + 45 45 164659 E-mail: nes@ddd-diagnostic.com Prepared: June 10, 2008
, 2. Device Information.
| Device: | |
|---|---|
Device Trade Name: CapIMAGE Device Model number: 9THY1660 Common Name: · Gamma Camera Classification name: Scintillation Gamma Camera Classification: Class I. 892.1100
3. Predicate Device Information.
| Predicate device: | Device Trade Name: CardioMD (initially Cardiocam). |
|---|---|
| Product code: | 90-KPS |
| 510(K): | K011611 |
1
Device Description. 4.
The CapIMAGE is a mobile Small Field of View (SFOV) gamma camera system utilizing a scintillation detector to detect gamma rays. The CapIMAGE is designed to be manually transported and deployed for scanning of patients in laying, sitting or standing positions. The system can operate powered from mains or from the internal battery source for at least 60 min.
Functional.
Analog signals from the photo multiplier tubes are summed into position and energy signals and sent to the camera console digitization and correction. The corrected data are hereafter send to a laptop PC located on top of the camera console, acting as a combined control and user interface to the system. Detector positioning is done using the persistence display mode on the PC, showing radioactive emission from the patient. The vertical detector positioning is motorised, all other positioning is done manually, using controls on the detector, including acquisition start and stop. The PC user interface (UI) enables the user to enter image acquisition parameters and to start and stop image acquisition. Following acquisition, images can be reviewed on the PC, processed and/or transferred to a peripheral device using DICOM
Performance characteristics.
| Energy range: | 59kev – 167kev |
|---|---|
| Detector UFOV: | Ø 210 mm (8.3") |
| Intrinsic Spatial Res.: | ≤ ± 3.7mm @ UFOV / FWHM |
| Energy Resolution: | ≤ 9.4% @ Tc-99m |
| Spatial Linearity: | ≤ ± 0.5mm @ UFOV |
| Flood Field Uniformity: | ≤ ± 2.7% @ UFOV Intrinsic |
| Intrinsic Uniformity, UFOV, Differential | 180k cps @ 20% loss |
| Spatial Resolution, FWHM, LEGP Tc-99m. |