(28 days)
Microvision™ Detail
Not Found
No
The device description and intended use focus on the physical properties of intensifying screens, with no mention of AI or ML.
No.
The device is described as radiographic intensifying screens used for high image quality radiographic examinations like mammography, which are diagnostic tools, not therapeutic.
No
The device described is an intensifying screen used in radiographic examinations to create images, not to interpret or diagnose from those images. Its role is in image acquisition, not diagnosis.
No
The device description explicitly states it is an "intensifying screen" made of physical materials (phosphor, lutetium tantalate), which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that these are "radiographic intensifying screens" used for "radiographic examination such as mammography." This describes a device used in conjunction with an imaging system to produce an image of the body, not a device used to test samples in vitro (outside the body).
- Device Description: The description details the physical components and materials of the screens, which are part of the imaging process, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
In summary, this device is a component of a radiographic imaging system, which is used for diagnostic purposes, but the device itself is not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
These screens are intended for use in radiographic procedures requiring high levels of image quality such as mammography.
These radiographic intensifying screens have application whenever a high image quality radiographic examination such as mammography is required.
Product codes
90 EAM
Device Description
Ultra-Vision® Mammography Detail and Ultra-Vision® Mammography Fast Detail are ultraviolethum astivated Primares Manziberghing Screens. The phosphor is niobium activated lutetium tantalate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Microvision™ Detail
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1960 Radiographic intensifying screen.
(a)
Identification. A radiographic intensifying screen is a device that is a thin radiolucent sheet coated with a luminescent material that transforms incident x-ray photons into visible light and intended for medical purposes to expose radiographic film.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
0
STERLIN
Diagnostic Imaging
DEC 2 2 1997
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the This Summans of SMDA 1990 and 21 CFR 807.92.
SUBMITTED BY: Jean E. Bartlett (864) 421-1836 Regulatory Affairs and Quality Assurance STERLING DIAGNOSTIC IMAGING, INC. PO Box 19048, Mail Drop 102 Greenville, SC 29602-9048 Fax # (864) 421-1635
DEVICE NAME: Ultra-Vision® Mammography Detail Ultra-Vision® Mammography Fast Detail
PREDICATE DEVICE: Microvision™ Detail
DEVICE DESCRIPTION AND INTENDED USE:
DE VICE DESCRIPTION AN INTER Vision® Mammography Fast Detail are ultraviolethum astivated Ultra-Vision® Mammography Delan and Onlia- Priores Manziberghing Screens. The phosphor is niobium activated lutetium tantalate.
These screens are intended for use in radiographic procedures requiring high levels of image quality such as mammography.
DEVICE COMPARISON TO PREDICATE DEVICE:
DE VICE COMI ARCOTT TO Price Detail and Ultra-Vision® Mammography Fast Detail are substantially The Other Vision Online grappy Detail as summarized below:
| | Ultra-
Vision®Mammography
Detail | Ultra-
Vision®Mammography
Fast Detail | Microvision Detail |
|---------------------------|----------------------------------------|---------------------------------------------|-----------------------|
| Phosphor | Lutetium Tantalate | Lutetium Tantalate | Gadolinium Oxysulfide |
| Speed | 1.17 | 1.53 | 1.0 |
| MTF @ 4cycles/mm | .675 | .635 | .635 |
| X-ray Absorption @ 25 kVp | .61 | .83 | .60 |
| Imaging Application | High Image quality | High Image quality | Mammography |
SUMMARY OF PRODUCT SIMILARITIES/DIFFERENCES
Signature: Jare Sattlett
Date: 11-19-97
Sterling Diagnostic Imaging, Inc. 10 South Academy Street P.O. Box 19048 Greenville, SC 29602-9048
1
Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of the department's name in a circular arrangement around a symbol. The symbol is composed of three stylized human figures, represented by flowing lines, suggesting a sense of movement and connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 2 1997
JeanE Bartlett Regulatory Affairs & Compliance Manager Sterling Diagnostic Imaging, Inc. 10 South Academy Street P.O. Box 19048 Greenville, SC 29602-9048
Re: K974423
Ultra-vision® Mammography Detail Ultra-vision® Mammography Fast Detail Dated: November 21, 1997 Received: November 24, 1997 Regulatory Class: I, Tier II 21 CFR 892.1960/Procode: 90 EAM
Dear Ms. Bartlett:
We have reviewed your Section 5100k) notification of intent to market the device referenced above and we have determined 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 Amendments, 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 prohibitions 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 Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marked 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference 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,
W.Liau Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal. Ear. Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
2
INDICATIONS STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Ultra-Vision® Mammography Detail Ultra-Vision® Mammography Fast Detail
Indications for Use:
These radiographic intensifying screens have application whenever a high image quality radiographic examination such as mammography is required.
""
(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 |
|---|---|
| ------------------------------------------ | --------------------- |
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
| 510(k) Number | K974423 |
|---|---|
| --------------- | --------- |