(101 days)
Not Found
No
The description focuses on standard gamma camera technology and performance metrics, with no mention of AI or ML in the device description, intended use, or performance studies. Image processing is mentioned but is stated to occur on a separate workstation not part of the QuantumCam system.
No.
The device is described as a diagnostic imaging device, used to produce images representing the internal distribution of radioactivity to assist in making clinical diagnoses. Its purpose is to characterize and show the state of organs or structures, not to treat or alleviate a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The system is intended for use as diagnostic imaging device." It further elaborates that the images can "assist in making clinical diagnoses by authorized medical personnel."
No
The device description explicitly states the system is comprised of a mechanical gantry and detectors, which are hardware components. While software is used for data acquisition and control, the core functionality relies on physical hardware.
Based on the provided text, the QuantumCam gamma camera system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- QuantumCam's Function: The QuantumCam directly images the distribution of a radiopharmaceutical within the human body. It detects gamma rays emitted from the radiopharmaceutical inside the patient, not from a sample taken from the patient.
- Intended Use: The intended use clearly states "imaging the distribution of a radiopharmaceutical within the human body" and "imaging procedures." This describes an in vivo (within the living organism) diagnostic process, not an in vitro one.
- Device Description: The description details a gamma camera system with detectors positioned near the patient, consistent with in vivo imaging.
Therefore, the QuantumCam is an in vivo diagnostic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The QuantumCam is a gamma camera system designed to acquire data for whole body static, gated or dynamic and multi-slice images. The system is intended for use as diagnostic imaging device. When used with appropriate radio pharmaceuticals, images are produced representing the internal distribution of radioactivity in head or body. The system allows you to acquire data for high resolution three dimensional, static, gated or dynamic images of biochemical and metabolic processes using Tc-99m, TI-201, I-123, In-111, Ga-67, Co-57.
Product codes
KPS
Device Description
The QuantumCam is a general purpose dual detector gamma camera system comprised of a mechanical gantry allowing the Detectors to be positioned and moved in close proximity to the patient for scanning. The Gantry provides for positioning of the detectors in location(s) suitable for patient to be brought in position for tomographic, whole body scanning as well as planar scanning in sitting or standing position.
The Detectors are standard Nal (Sodium lodide) / Photomultiplier based scintillation detectors designed following the Anger Camera principles first described by Hal Oscar Anger. This detector technology has been used effectively in Nuclear Medicine for decades. The Detectors are equipped with standard Collimators following the principles known to the industry. The image data from the detectors are collected by hardware in the detector and the data acquisition is controlled by software running on a standard personal computer with a suitable operating system. The data may subsequently be transferred to a Nuclear Medicine Workstation for processing and interpretation. This Workstation is not part of the QuantumCam system.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Gamma camera system
Anatomical Site
Head or body (internal distribution of radioactivity in head or body)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Authorized 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 data has been obtained according to DDD quality system procedures as investigations performed according to standards as listed below, conducted and reported by qualified experts:
Intrinsic Spatial Resolution, FWHM, UFOV @ surface. 320 kcps
Count rate Sensitivity, @ 20 % loss. > 225 kcps
Detector shielding Sensitivity, @ 184 keV.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. 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 II.
0
K140206
Page 1 of 5
MAY 0 8 2014
510(k) Submission, QuantumCam
1PMN2618-A03
Diagnostic
25 November 2013
| 5. | 510(k) Summary or 510(k) Statement | |
|---|---|---|
| 5.1 | 510(k) Summary | |
| Ref. to 21 CFR 807.92 | ||
| 1 | Submitted by: | DDD-Diagnostic A/S |
| Dr. Neergaards Vej 5E | ||
| 2970 Horsholm, Denmark | ||
| Tel: + 45 45 768888 | ||
| Fax: + 45 45 164659 | ||
| Contact person: Trine Olesen | ||
| Tel: +45 45 768888 | ||
| Fax: + 45 45 164659 | ||
| E-mail: trine.olesen@ddd-diagnostic.dk | ||
| Preparation date: November 25, 2013 | ||
| 2 | Device Trade Name: | QuantumCam (Commercial name) |
| (BodyMD is the development name) | ||
| Common Name: | Gamma Camera System | |
| Classification name: | Emission computed tomography system | |
| 3 | Predicate Device: | UNICORN MODEL SYS0630 (later renamed as Meridian), |
| DDD-Diagnostic A/S | ||
| 510(k) Number: | K001888 | |
| 4 | Device description: | The QuantumCam is a general purpose dual detector gamma camera |
| system comprised of a mechanical gantry allowing the Detectors to | ||
| be positioned and moved in close proximity to the patient for | ||
| scanning. The Gantry provides for positioning of the detectors in | ||
| location(s) suitable for patient to be brought in position for | ||
| tomographic, whole body scanning as well as planar scanning in | ||
| sitting or standing position. | ||
| 510(k) Submission, QuantumCam | ||
| 1PMN2618-A03 | 25 November 2013 | |
| Functional description: | The Detectors are standard Nal (Sodium lodide) / Photomultiplier | |
| based scintillation detectors designed following the Anger Camera | ||
| principles first described by Hal Oscar Anger. This detector | ||
| technology has been used effectively in Nuclear Medicine for | ||
| decades. The Detectors are equipped with standard Collimators | ||
| following the principles known to the industry. The image data from | ||
| the detectors are collected by hardware in the detector and the data | ||
| acquisition is controlled by software running on a standard personal | ||
| computer with a suitable operating system. The data may | ||
| subsequently be transferred to a Nuclear Medicine Workstation for | ||
| processing and interpretation. This Workstation is not part of the | ||
| QuantumCam system. | ||
| 5 Intended use: | The intended use of the QuantumCam gamma camera system is to | |
| perform general nuclear medicine imaging procedures. This is | ||
| intended to be accomplished by imaging the distribution of a | ||
| radiopharmaceutical within the human body. | ||
| Gamma rays emitted from the radiopharmaceutical are detected by | ||
| the gamma camera system and formed into images characterizing | ||
| and showing the state of organs or structures in the form of | ||
| functional images. When QuantumCam is connected to a nuclear | ||
| medicine workstation, these images can be used in concert with | ||
| other clinical data to assist in making clinical diagnoses by authorized | ||
| medical personnel. | ||
| Indications for use. | ||
| The QuantumCam is a gamma camera system designed to acquire | ||
| data for whole body static, gated or dynamic and multi-slice images. | ||
| The system is intended for use as diagnostic imaging device. When | ||
| used with appropriate radio pharmaceuticals, images are produced | ||
| representing the internal distribution of radioactivity in head or body. | ||
| The system allows you to acquire data for high resolution three | ||
| dimensional, static, gated or dynamic images of biochemical and | ||
| metabolic processes using Tc-99m, TI-201, I-123, In-111, Ga-67, Co- |
-
| |
| 6 a Summary of technological
characteristics: | The submitted device has the same technological and functional
characteristics as the predicate device. However, the gantry with
patient support device is in design different. | |
| | Submitted device:
QuantumCam, 9SYS2070 | Predicate device:
Unicorn model, SYS0630 |
| Design: | The QuantumCam is an open
gantry design supported on an
open base frame. The complete
system is comprised of: a gantry
base, detector tower, detector
gear box and two imaging
detectors, collimator cart, PC,
and electronics including a main
PSU. | Lightweight compact casted
aluminum ring gantry supporting a
single detector in an unbalanced
design. The complete gantry is
comprised of: a ring gantry, a detector, a patient table, a
collimator cart, PC, and electronics
including a main PSU. |
| Material: | The QuantumCam employs
detector of scintillation crystals
in a traditional Anger design. The
gantry and patient table employs
steel and anodized aluminum,
steel plate and aluminum covers. | The predicate device employs a
traditional detector Anger design
of scintillation crystals and PM
tubes. The gantry employs casted
and extruded aluminum, steel
plate and fiberglass covers. |
| Energy source: | Mains supply.
200VAC - 240VAC | Mains supply.
100VAC - 240VAC |
| Detector: | The QuantumCam has two
separate detectors. Each
detector casting is supported by
means of a U-shaped detector
arm in a balanced design
enabling manual tilt of the
detector. The complete detector
is comprised of: a detector
casting, a Nal detector crystal,
PM tubes, collimators and
electronics for data processing. | The detector is supported by
means of 2 casted aluminum
brackets secured to the side of a
gantry bearing by means of 2
linear bearings. The linear
bearings enables radial detector
positioning and detector tilt. The
detector is a reinforced casted
lead housing. |
1
Image /page/1/Picture/0 description: The image shows a logo with three overlapping "D" letters in bold, black font. Below the letters, the word "Diagnostic" is written in a smaller, sans-serif font. The letters are arranged in a way that creates a sense of depth and layering. The overall design is simple and professional.
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Image /page/2/Picture/0 description: The image shows the logo for DDD Diagnostic. The logo consists of three overlapping "D" letters. The word "Diagnostic" is written in a smaller font size below the three "D" letters.
1PMN2618-A03
510(k) Submission, QuantumCam
1 - 1 - 1 - 1 - 1 -
25 November 2013
5-3
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Image /page/3/Picture/0 description: The image shows the logo for DDD Diagnostic. The logo consists of three overlapping "D" letters in a bold, sans-serif font. Below the letters, the word "Diagnostic" is written in a smaller, simpler font.
510(k) Submission, QuantumCam
1PMN2618-A03
25 November 2013
| Software: | ||
|---|---|---|
| The QuantumCam acquisition station is based on a PC architecture with Windows 7 64bit operating system and Microsoft SQL for database handling. A dedicated S/W package for Graphic User Interface (GUI) - S/W package for acquisition setup and gantry/detector motion control. The package also includes means for data transmission via an external network. | The predicate device acquisition station is based on a PC architecture with Windows NT 4.0, SP 6+ operating system. The system is controlled by a software package formed by a dedicated Software (S/W) package for Graphic User Interface (GUI) and a dedicated S/W package designed for the purpose of controlling system setup, gantry/table motions and acquisition and data transfer. |
- 6 b Description of how the non clinical test results have been collected:
.
Non clinical data has been obtained according to DDD quality system procedures as investigations performed according to standards as listed below, conducted and reported by qualified experts:
| Specifications: | ||
|---|---|---|
| Intrinsic Spatial | ||
| Resolution, FWHM, UFOV | ||
| @ surface. | ||
| $\leq \pm 3.9$ mm | Test equipment used, test setup and all | |
| calculations have all been performed according | ||
| to the NEMA Standard NU 1:2007 in a 20% | ||
| energy. | ||
| Spatial Resolution, FWHM, | ||
| LEGP collimator @ 10cm, | ||
| Tc-99m. | ||
| $ 320 kcps | Test equipment used, test setup and all | |
| calculations have all been performed according | ||
| to the NEMA Standard NU 1:2007 in a 20% | ||
| energy. | ||
| Count rate Sensitivity, @ | ||
| 20 % loss. |
225 kcps | Test equipment used, test setup and all
calculations have all been performed according
to the NEMA Standard NU 1:2007 in a 20%
energy. |
| Detector shielding
Sensitivity, @ 184 keV.