(434 days)
Not Found
No
The document describes standard nuclear medicine imaging technology and software for image processing, but there is no mention of AI or ML algorithms being used for image analysis, interpretation, or any other function.
No
The device is used for imaging and diagnostic purposes (imaging the distribution of radionuclides in the body), not for treating a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is "intended for use in the generation of clinical images in Nuclear Medicine applications" and "produces images depicting the anatomical distribution of radioisotopes within the human body for interpretation by authorized medical personnel." This process of generating images for interpretation to understand the distribution of radionuclides and their clinical implications is inherently diagnostic.
No
The device description explicitly states that the system consists of an Imaging Head, an Arm and Cart assembly, and a computer with hardware components (PC, Video Display Terminal, Keyboard, optional Printer) in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for generating clinical images in Nuclear Medicine applications by imaging the distribution of radionuclides in the body. This is an in vivo application (within a living organism), not an in vitro application (outside the body, typically on biological samples).
- Device Description: The description details a gamma camera system designed to detect emissions from radiopharmaceuticals within the human body.
- Input Imaging Modality: The input modality is a gamma camera, which is used for in vivo imaging in Nuclear Medicine.
IVD devices are designed to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. This device operates by imaging the distribution of substances within the body.
N/A
Intended Use / Indications for Use
The Notebook Imager™ is a gamma camera system which is intended for use in the generation of clinical images in Nuclear Medicine applications. Specifically, the Notebook Imager™ is intended to image the distribution of radionuclides in the body. In so doing, the system produces images depicting the anatomical distribution of radioisotopes within the human body for interpretation by authorized medical personnel.
For Nuclear Medicine Imaging Device
A. Planar imaging: Yes, Energy Range (KeV): 30-300
B. Whole Body imaging: No
C. Tomographic imaging (SPECT) for non-Positron emitter: No
D. Positron imaging by coincidence: No
E. Positron imaging without coincidence: No
F. Other indication(s) in the device label, but not included in above list: To image the distribution of radionuclide in the human body.
Product codes (comma separated list FDA assigned to the subject device)
90 IYX
Device Description
The Notebook Imager™ system is a gamma camera which consists of an Imaging Head, an Arm and Cart assembly, and SITCO Nuclear Medicine software. The computer consists of a PC, Video Display Terminal, Keyboard, optional Printer and processing Software. The Imaging Head consists of a two-dimensional array of room-temperature, solid-state gamma-ray detectors with readout circuitry for constructing planar images of the emission from radiopharmaceuticals. This array consists of from 1 to 64 identical one-inchby-one-inch imaging modules, each containing 64 (8x8) cadmium-zinctelluride (CZT) semi-conductor detector elements mounted on a multichip submodule. The multichip submodule provides amplification of the input signals and identifies the address of the detector element in which each incoming photon is absorbed.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Gamma camera
Anatomical Site
Human 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)
No clinical testing was necessary.
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.
K921296, KAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA, K885054
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
K96/1104
MAY 28 1997
510(k) Notification for Notebook Imager™
Appendix VII, Page 25
Appendix VII
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA
This Summary of 510(k) Safety and Effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
General Information L
| A. Submitted By: | DIGIRAD Corporation
7408 Trade Street
San Diego, CA 92121-2410 |
|-------------------------|----------------------------------------------------------------------|
| Contact Person: | Clinton L. Lingren |
| B. Classification Name: | Scintillation (gamma) camera |
| Common/Usual Name: | Gamma Camera |
| Trade Name: | Notebook Imager™ |
- C. Predicate Devices:
| Sponsor | Product | 510(k) No. |
|---|---|---|
| ADAC | Transcam | K921296 |
| ELSCINT | APEX SPX-4 | KAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA |
| SCINTICOR | SIM 400 | K885054 |
- D. Device Description:
The Notebook Imager™ system is a gamma camera which consists of an Imaging Head, an Arm and Cart assembly, and SITCO Nuclear Medicine software. The computer consists of a PC, Video Display Terminal, Keyboard, optional Printer and processing Software. The Imaging Head consists of a two-dimensional array of room-temperature, solid-state gamma-ray detectors with readout circuitry for constructing planar images of the emission from radiopharmaceuticals. This array consists of from 1 to 64 identical one-inchby-one-inch imaging modules, each containing 64 (8x8) cadmium-zinctelluride (CZT) semi-conductor detector elements mounted on a multichip submodule. The multichip submodule provides amplification of the input signals and identifies the address of the detector element in which each incoming photon is absorbed.
1
E. Intended Use:
The Notebook Imager™ is a gamma camera system which is intended for use in the generation of clinical images in Nuclear Medicine applications. Specifically, the Notebook Imager™ is intended to image the distribution of radionuclides in the body. In so doing, the system produces images depicting the anatomical distribution of radioisotopes within the human body for interpretation by authorized medical personnel.
- Substantial Equivalence: F.
The Notebook Imager™ has the same intended use, uses the same principle of radiation detection, and has very similar performance characteristics as the predicate devices; the ADAC Transcam, K921296, the Elscint APEX SPX-4, and the SCINTICOR SIM-400, K885054. The main difference is that the Notebook Imager™ uses CdZnTe semiconductor detector elements, which eliminate the conventional Nal crystal, the PMTs, and, as a result, most of the volume and weight of those camera heads and improves substantially the spatial resolution. When compared to the conventional camera system, these changes will have either no effect on the patient's safety, or rather decrease the risk to the patients, because of the reduced weight of the detector.
II. Clinical Tests:
No clinical testing was necessary.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three stylized human figures.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Clinton L. Lingren Regulatory and Patent Liaison Officer DIGIRAD 7408 Trade Street San Diego, CA 92121-2410
MAY 2 8 1997
Re: K961104 Notebook Imager™ (Gamma Camera) Dated: February 26, 1997 Received: February 27, 1997 Regulatory Class: I 21 CFR 892.1100/Procode: 90 IYX ...
Dear Mr. Lingren:
We have reviewed your Section 510k) notification of intent to market the device referenced above and we have decembed the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendances or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 problibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the England Register. Please note: this response to your premation submission does not affect any obligation you might have under sections 51 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 80) and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misterance to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
William Yu
Lillian Yin, Ph.D. Division Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page_1_of_1_
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indication For Use:
For Nuclear Medicine Imaging Device
| Yes | No | Energy Range (KeV) | ||
|---|---|---|---|---|
| A. | Planar imaging | X | - | 30-300 |
| B. | Whole Body imaging | - | X | |
| C. | Tomographic imaging (SPECT) for non-Positron emitter | - | X | |
| D. | Positron imaging by coincidence | - | X | |
| E. | Positron imaging without coincidence | - | X |
Other indication(s) in the device label, F. but not included in above list
To image the distribution of
radionuclide in the human body.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ (Per 21 CFR 801.109) OR
Over-the-Counter Use_
David A. Symm
(Division Sign-Off)
(Division Sign-Off) (Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number