(57 days)
Not Found
No
The summary describes a standard digital intraoral sensor system for capturing x-ray images and explicitly states that mentions of AI, DNN, or ML were not found.
No
The device is described as capturing diagnostic x-ray radiographs, indicating a diagnostic function rather than a therapeutic one (treatment).
Yes
The "Intended Use / Indications for Use" section explicitly states that "Snapshot is intended to be used by dentists and other qualified professionals for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures."
No
The device description explicitly states that the system consists of a Sensor, Workstation software, Sensor holders, and hygienic covers. The sensor is a hardware component essential to the device's function of capturing x-ray images.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to produce diagnostic x-ray radiographs of oral structures. This is a form of in vivo imaging, meaning it involves examining structures within a living organism.
- Device Description: The device captures intraoral digital dental x-ray images. This process involves interacting directly with the patient's body (taking an x-ray).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform such tests on samples.
Therefore, Snapshot falls under the category of a medical imaging device used for diagnostic purposes, but it is not an IVD.
N/A
Intended Use / Indications for Use
Snapshot is intended to be used by dentists and other qualified professionals for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.
Product codes (comma separated list FDA assigned to the subject device)
MUH
Device Description
Snapshot is a digital intraoral sensor system that can be connected to a workstation PC via USB connection. The essential function and purpose of the system in a dental clinic is to capture intraoral digital dental x-ray images. The system can be used with general intraoral X-ray units.
Snapshot utilizes existing designs and share parts with the predicate Sigma M sensor. The sensor is the same CMOS sensor as that of the predicate device. USB 2.0 High speed connection is used for image transfer to a PC.
The basic system consists of
- Sensor, which is available in two sizes
- . Workstation software
- . Sensor holders and hygienic covers
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
dentition, jaws and other oral structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentists and other qualified professionals
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)
Not Found
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
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for INSTRUMENTARIUM. The logo consists of a stylized lowercase "i" inside of a circle on the left, followed by the word "INSTRUMENTARIUM" in all caps. The font is a simple sans-serif typeface.
SEP - 2 2008
510(k) Summary
Date:
June 26, 2008
Manufacturer:
Instrumentarium Dental, PaloDEx Group Oy Nahkelantie 160 04300 Tuusula, Finland
Tel: +358 45 7882 2000 Fax: +358 9 851 4048
Contact person: Mr. Jouni Onnela, Tel +358 40 747 2550
United States Sales Representative (U.S. Designated agent):
INSTRUMENTARIUM DENTAL INC. 300 West Edgerton Ave. Milwaukee, WI 53207 -6025 Tel: +1 414 747 1030, 800 558 6120 Fax: +1 414 481 8665
Contact Person: Mr. Frank Kashinski, Tel +1 414 747 6315
Trade name:
Snapshot
Common name:
Digital intraoral sensor system.
Classification name:
System, x-ray, extraoral source, digital (21 CFR 872.1800, product code MUH)
Predicate device:
.
Sigma M, K063837, MUH
Description:
Snapshot is a digital intraoral sensor system that can be connected to a workstation PC via USB connection. The essential function and purpose of the system in a dental clinic is to capture intraoral digital dental x-ray images. The system can be used with general intraoral X-ray units.
Snapshot utilizes existing designs and share parts with the predicate Sigma M sensor. The sensor is the same CMOS sensor as that of the predicate device. USB 2.0 High speed connection is used for image transfer to a PC.
The basic system consists of
- Sensor, which is available in two sizes
- . Workstation software
- . Sensor holders and hygienic covers
1
Image /page/1/Picture/0 description: The image shows the word "INSTRUMENTARIUM" next to a logo. The logo is a stylized letter "i" inside of a circle. The text is in all caps and appears to be a sans-serif font.
Intended use:
Snapshot is intended to be used by dentists and other qualified professionals for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.
Technological characteristics:
Snapshot has the same sensor design and materials as the predicate device. The terminal unit between the sensor and a PC is smaller in size than that of the predicate device. The energy source is USB from the PC compared to the rechargeable battery of the predicate device. USB 2.0 High speed connection is used for image transfer to the PC compared to wireless image transfer (WLAN) of the predicate device.
Substantial Equivalence:
We consider Snapshot is similar in design, composition and function to the predicate device Sigma M, K063837, MUH.
The comparison of characteristics also by following the guidance document "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" supports substantial equivalence.
As conclusion Snapshot is as safe, as effective, and performs as well as or better than the predicate device.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 2 2008
Mr. Jouni Onnela Regulatory Manager Instrumentarium Dental, PaloDEx Group Oy Nahkelantie 160 Tuusula, 00430 FINLAND
Re: K081925
Trade/Device Name: Snapshot Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: June 26, 2008 Received: July 7, 2008
Dear Mr. Onnela:
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 (PMA), 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.
3
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I toase oc actived that I be results at your device complies with other requirements of the Act that IDA has inder a decornments administered by other Federal agencies. You must or any I catal statutios and regarations, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of K Part 807), incenter (21 (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) I mis lotter with and in your e finding of substantial equivalence of your device to a legally promation notinetation " 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.
Sincerely vours.
Nancy C. Brogdon
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 the logo for Instrumentarium. The logo consists of a stylized letter "i" inside of a circle on the left, followed by the word "INSTRUMENTARIUM" in a simple, sans-serif font. The logo is black and white.
Indications for Use
08/925 510(k) Number (if known):
Device Name: Snapshot
Indications for Use:
Snapshot is intended to be used by dentists and other qualified professionals for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number