(54 days)
Not Found
No
The summary does not mention AI, ML, deep learning, or any related terms, and the description focuses on hardware and standard imaging acquisition.
No
This device is for acquiring images for diagnosis, not for treating a condition.
Yes
The device acquires SPECT and Planar gamma camera images, which are used by medical professionals to diagnose various conditions. The performance studies section also mentions the acquisition of clinical images in human subjects, further supporting its diagnostic use.
No
The device description explicitly states it includes "hardware and software components" and describes physical hardware like an open gantry, patient chair, and detectors.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "acquisition of Single Photon Emission Computed Tomography (SPECT) and Planar gamma camera images." This describes an imaging device used to capture images of the body, not a device used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to diagnose or monitor a condition.
- Device Description: The description details a physical imaging system with detectors, a patient chair, and hardware/software for image acquisition. This aligns with the description of an imaging device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostic testing.
The device is clearly an imaging device used for medical imaging procedures.
N/A
Intended Use / Indications for Use
For use in the acquisition of Single Photon Emission Computed Tomography (SPECT) and Planar gamma camera images.
Product codes (comma separated list FDA assigned to the subject device)
KPS
Device Description
The C! SPECT Imaging System is an open gantry (with no external moving parts), upright seated device with an integrated patient chair, an acquisition station, two detectors, and hardware and software components. The patient chair is mechanized to accommodate patient loading and centering in the detector field of view.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Single Photon Emission Computed Tomography (SPECT) and Planar gamma camera images.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Performance testing was performed using NEMA NU1 phantoms, under the NEMA Standard test protocols. In all cases, performance of the C! device met or exceeded that of predicate devices.
Clinical images were obtained using the C! in human subjects. Tomographic image quality was at least equal to images produced by reference predicate devices.
Furthermore, electrical safety testing has been performed and found to meet applicable standards and defined acceptance criteria.
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
§ 892.1200 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
Image /page/0/Picture/0 description: The image shows a logo or emblem that includes the word "Photon" with a superscripted "2". To the left of the word "Photon" is a stylized graphic that resembles a flower or an asterisk-like symbol. The text is slightly stylized with a cursive-like font.
14350 S.W. 142nd Ave., Miami, FL 33186 Phone: 305-234-0836
Image /page/0/Picture/2 description: The image shows the number K070589 in a handwritten style. Below the number, the text "510(k) Premarket Notification" is printed. The text indicates that the image is related to a premarket notification document, possibly for a medical device or other product requiring FDA approval.
SECTION G 510(K) SUMMARY
In accordance with 21CFR 807.92
APR 2 4 2007
1.0 Submitter Information
| Name: | Transphoton Corporation
(dba Photon²) |
|----------|--------------------------------------------|
| Address: | 14350 S.W. 142nd Avenue
Miami, FL 33186 |
| Phone: | 305-234-0836 |
| Fax: | 305-234-2398 |
Contact Person: Brant Wigger, Chief Operations Officer
Date of Submission: February 28, 2007
2.0 Device Identification
| Name of Device: | C! SPECT Imaging System |
|---|---|
| Common Name: | Gamma Camera – SPECT Imaging System |
| Classification Name: | Emission Computed Tomography System (ECT) |
3.0 Predicate Devices
-
- Myolight GE Medical Systems F.I. Haifa [K033874]
-
- CardiArc Ltd. -- CardiArc SPECT Imaging Device [K053062]
-
- Transphoton Corporation APEX XL-4 [K033001]
4.0 Intended Use / Indications for Use
For use in the acquisition of Single Photon Emission Computed Tomography (SPECT) and Planar gamma camera images.
1
Image /page/1/Picture/0 description: The image shows a logo with the word "Photon" and a superscript "2". To the left of the word is a small, complex graphic that looks like a collection of small circles or a stylized flower. To the right of the word is a star symbol. The text and symbols are in black, set against a white background.
5.0 Technological Characteristics
The C! SPECT Imaging System is an open gantry (with no external moving parts), upright seated device with an integrated patient chair, an acquisition station, two detectors, and hardware and software components. The patient chair is mechanized to accommodate patient loading and centering in the detector field of view.
Thus, the C! SPECT Imaging System raises no new issues of safety or efficacy.
6.0 Performance Testing and Data
Performance testing was performed using NEMA NU1 phantoms, under the NEMA Standard test protocols. In all cases, performance of the C! device met or exceeded that of predicate devices.
Clinical images were obtained using the C! in human subjects. Tomographic image quality was at least equal to images produced by reference predicate devices.
Furthermore, electrical safety testing has been performed and found to meet applicable standards and defined acceptance criteria.
7.0 Substantial Equivalence
The C! SPECT Imaging System has the same intended use, similar principles of operation, and consistent technological characteristics as the predicate devices. Thus, the C! is substantially equivalent to the predicate devices and no new safety or effectiveness concerns are raised.
2
Image /page/2/Picture/0 description: The image shows a circular logo for the Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol consists of three curved lines that resemble a person's profile.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR 2 4 2007
Mr. Brant Wigger Chief Operations Officer Transphoton Corporation (dba Photo2) 14350 S. W. 142nd Avenue MIAMI FL 33186
Re: K070589
Trade/Device Name: C! Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: February 28, 2007 Received: March 1, 2007
Dear Mr. Wigger:
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top and "Centennial" in the middle. The letters "FDA" are prominently displayed in the center of the logo. Three stars are located at the bottom of the logo. The logo appears to be a commemorative emblem for the centennial of the FDA.
Protecting and Promoting Public Health
3
Page 2 -
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 guality 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a 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 contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows a stylized logo or graphic that includes the word "Photon" with a superscript "2". To the left of the word, there is a design that resembles a flower or an abstract geometric shape. To the right of the word, there is a starburst or sun-like symbol, adding a sense of energy or light to the overall design.
14350 S.W. 142nd Ave., Miami, FL 33186 Phone: 305-234-0836
Ci 510(k) Premarket Notification
Indications for Use Form
Page 1 of 1
510(k) Number (if known):
K070589
Device Name: C!
Indications For Use:
The C! is indicated for use in the acquisition of Single Photon Emission Computed Tomography (SPECT) and Planar gamma camera images.
(Please do not write below this line-continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: X (Per 21 CFR 801.109)
OR
Over-The-Counter Use:
David h. hayson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 17050 510(k) Number __